| 1. Title: Plan B for 17-year olds. Source: Medical Letter On Drugs and Therapeutics. 2009 May 18;51(1312):40. Abstract: The FDA has announced that it will lower the age for over-the-counter access to the emergency contraceptive Plan B from 18 to 17 years old. In a randomized, controlled trial, the two 0.75-mg levonorgestrel tablets in Plan B, taken 12 hours apart beginning within 72 hours after unprotected intercourse, decreased the overall pregnancy rate to 1.1% (11/976) of women who requested emergency contraception. The sooner the drug is taken after coitus, the more effective it is. Nausea and vomiting can occur with Plan B. Fetal malformations have not been associated with pregnancies that occurred despite use of levonorgestrel-only emergency contraception. (full-text) Language: English Keywords: UNITED STATES OF AMERICA | USFDA | ADOLESCENTS | EMERGENCY CONTRACEPTION | ADMINISTRATION AND DOSAGE | PROGRAM ACCESSIBILITY | Developed Countries | North America | Americas | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Program Evaluation | Programs | Organization and Administration Document Number: 341625 |
2.  Title: Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. Author: Centers for Disease Control and Prevention (CDC) Source: MMWR. Morbidity and Mortality Weekly Report. Recommendations and Reports. 2009 Apr 10;58(RR-4):[216] p.. Abstract: Major changes in the guidelines include 1) greater emphasis on the importance of antiretroviral therapy for the prevention and treatment of opportunistic infections (OIs), especially those OIs for which no specific therapy exists; 2) information regarding the diagnosis and management of immune reconstitution inflammatory syndromes; 3) information regarding the use of interferon-gamma release assays for the diagnosis of latent tuberculosis (TB) infection; 4) updated information about drug interactions that affect the use of rifamycin drugs for prevention and treatment of TB; 5) the addition of a section on hepatitis B virus infection; and 6) the addition of malaria to the list of OIs that might be acquired during international travel. Language: English Keywords: UNITED STATES OF AMERICA | SUMMARY REPORT | STANDARDS | MANUAL | ADULTS | ADOLESCENTS | PERSONS LIVING WITH HIV/AIDS | HIV INFECTIONS | HIV PREVENTION | TREATMENT | ANTIRETROVIRAL THERAPY | DRUG INTERACTIONS | EXAMINATIONS AND DIAGNOSES | Developed Countries | North America | Americas | Research Methodology | Age Factors | Population Characteristics | Demographic Factors | Population | Youth | Viral Diseases | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV | Drugs Document Number: 339985 |
| 3. Title: Why women and girls need an AIDS vaccine. The search for new and better prevention options. Author: International AIDS Vaccine Initiative [IAVI] Source: [New York, New York], IAVI, 2009. 4 p. (iavi INFOsheet) Abstract: Women’s and girls’ increased biological vulnerability to HIV infection, coupled with social and economic inequities, fuel the pandemic in resource-limited nations. This information sheet addresses some of the gender norms and inequalities that impede women’s ability to prevent HIV infection and makes the case for development of an AIDS vaccine as a powerful equity tool. Language: English Keywords: GLOBAL | SUMMARY REPORT | ADOLESCENTS, FEMALE | PERSONS LIVING WITH HIV/AIDS | AIDS | STIGMA | SOCIAL DISCRIMINATION | PHYSICAL ABUSE | SEXUAL ABUSE | VACCINES | MICROBICIDES | WOMEN'S HEALTH | RESEARCH AND DEVELOPMENT | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Social Problems | Sociocultural Factors | Violence | Behavior | Crime | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment | Technology | Economic Factors Document Number: 331832 |
4.  Peer Reviewed Title: Evaluation of mifepristone as a once a month contraceptive pill. Author: Agarwal M; Das V; Agarwal A; Pandey A; Srivastava D Source: American Journal of Obstetrics and Gynecology. 2009 May;200(5):e27-9. Abstract: OBJECTIVE: The purpose of this study was to assess the efficacy and safety of mifepristone as a contraceptive pill. STUDY DESIGN: A prospective case-control study was conducted in a tertiary care center of North India. The study group (n = 86) was given 200-mg mifepristone tablets on the 16th day of the menstrual cycle. The control group (n = 92) received combined oral contraceptive (COC) as per protocol. Subjects were followed for drug compliance, satisfaction, side effects, and failure. RESULTS: Acceptability of mifepristone was significantly higher in educated population (P < .001), with fewer side effects (P = .001), good satisfaction (P < .001), and higher compliance rate (P = .05). The oral contraceptive pill group had higher adverse biochemical parameters. CONCLUSION: Mifepristone can be used as a monthly contraceptive pill effectively. Language: English Keywords: INDIA | RESEARCH REPORT | ORAL CONTRACEPTIVES | RU-486 | TIME FACTORS | ADMINISTRATION AND DOSAGE | Asia, Southern | Asia | Developing Countries | Contraceptive Methods | Contraception | Family Planning | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Population Dynamics | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341243 |
| 5. Peer Reviewed Title: Enhanced immunogenicity of an oral inactivated cholera vaccine in infants in Bangladesh obtained by zinc supplementation and by temporary withholding breast-feeding. Author: Ahmed T; Svennerholm AM; Al Tarique A; Sultana GN; Qadri F Source: Vaccine. 2009 Feb 25;27(9):1433-9. Abstract: The killed oral cholera vaccine Dukoral is recommended for adults and only children over 2 years of age, although cholera is seen frequently in younger children and there is an urgent need for a vaccine for them. Since decreased immunogenicity of oral vaccines in children in developing countries is a critical problem, we tested interventions to enhance responses to Dukoral. We evaluated the effect on the immune responses by temporarily withholding breast-feeding or by giving zinc supplementation. Two doses of Dukoral consisting of killed cholera vibrios and cholera B subunit were given to 6-18 months old Bangladeshi children (n=340) and safety and immunogenicity studied. Our results showed that two doses of the vaccine were safe and induced antibacterial (vibriocidal) antibody responses in 57% and antitoxin responses in 85% of the children. Immune responses were comparable after intake of one and two doses. Temporary withholding breast-feeding for 3 h before immunization or supplementation with 20 mg of zinc per day for 42 days resulted in increased magnitude of vibriocidal antibodies (77% and 79% responders, respectively). Administration of vaccines without buffer or in water did not result in reduction of vibriocidal responses. This study demonstrates that the vaccine is safe and immunogenic in children under 2 years of age and that simple interventions can enhance immune responses in young children. Language: English Keywords: BANGLADESH | RESEARCH REPORT | INFANT | CHOLERA | ZINC | HUMAN MILK | VACCINES | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE USE-EFFECTIVENESS | AUTOIMMUNE RESPONSE | SAFETY | Developing Countries | Asia, Southern | Asia | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Bacterial and Fungal Diseases | Infections | Diseases | Metals | Vitamins and Minerals | Physiology | Biology | Lactation | Maternal Physiology | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment | Contraceptive Effectiveness | Contraception | Family Planning | Antibodies | Immunologic Factors | Immunity | Immune System | Public Health Document Number: 341051 |
| 6. Peer Reviewed Title: Risk factors for virological failure and subtherapeutic antiretroviral drug concentrations in HIV-positive adults treated in rural northwestern Uganda. Author: Ahoua L; Guenther G; Pinoges L; Anguzu P; Chaix ML; Le Tiec C; Balkan S; Olson D; Olaro C; Pujades-Rodriguez M Source: BMC Infectious Diseases. 2009;9:81. Abstract: BACKGROUND: Little is known about immunovirological treatment outcomes and adherence in HIV/AIDS patients on antiretroviral therapy (ART) treated using a simplified management approach in rural areas of developing countries, or about the main factors influencing those outcomes in clinical practice. METHODS: Cross-sectional immunovirological, pharmacological, and adherence outcomes were evaluated in all patients alive and on fixed-dose ART combinations for 24 months, and in a random sample of those treated for 12 months. Risk factors for virological failure (>1,000 copies/ml) and subtherapeutic antiretroviral (ARV) concentrations were investigated with multiple logistic regression. RESULTS: At 12 and 24 months of ART, 72% (n = 701) and 70% (n = 369) of patients, respectively, were alive and in care. About 8% and 38% of patients, respectively, were diagnosed with immunological failure; and 75% and 72% of patients, respectively, had undetectable HIV RNA (<400 copies/ml). Risk factors for virological failure (>1,000 copies/ml) were poor adherence, tuberculosis diagnosed after ART initiation, subtherapeutic NNRTI concentrations, general clinical symptoms, and lower weight than at baseline. About 14% of patients had low ARV plasma concentrations. Digestive symptoms and poor adherence to ART were risk factors for low ARV plasma concentrations. CONCLUSION: Efforts to improve both access to care and patient management to achieve better immunological and virological outcomes on ART are necessary to maximize the duration of first-line therapy. Language: English Keywords: UGANDA | RESEARCH REPORT | RURAL AREAS | CLIENTS | PERSONS LIVING WITH HIV/AIDS | ANTIRETROVIRAL THERAPY | TREATMENT | ADMINISTRATION AND DOSAGE | PROGRAM ACCESSIBILITY | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Geographic Factors | Population | Program Activities | Programs | Organization and Administration | HIV Infections | Viral Diseases | Diseases | HIV | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Program Evaluation Document Number: 342064 |
| 7. Peer Reviewed Title: Diarrhoeagenic Escherichia coli are not a significant cause of diarrhoea in hospitalised children in Kuwait. Author: Albert MJ; Rotimi VO; Dhar R; Silpikurian S; Pacsa AS; Molla AM; Szucs G Source: BMC Microbiology. 2009;9:62. Abstract: BACKGROUND: The importance of diarrhoeagenic Escherichia coli (DEC) infections in the Arabian Gulf including Kuwait is not known. The prevalence of DEC (enterotoxigenic [ETEC], enteropathogenic [EPEC], enteroinvasive [EIEC], enterohemorrhagic [EHEC] and enteroaggregative [EAEC]) was studied in 537 children < or = 5 years old hospitalised with acute diarrhoea and 113 matched controls from two hospitals during 2005-07 by PCR assays using E. coli colony pools. RESULTS: The prevalence of DEC varied from 0.75% for EHEC to 8.4% for EPEC (mostly atypical variety) in diarrhoeal children with no significant differences compared to that in control children (P values 0.15 to 1.00). Twenty-seven EPEC isolates studied mostly belonged to non-traditional serotypes and possessed beta and theta intimin subtypes. A total of 54 DEC isolates from diarrhoeal children and 4 from controls studied for antimicrobial susceptibility showed resistance for older antimicrobials, ampicillin (0 to 100%), tetracycline (33 to 100%) and trimethoprim (22.2 to 100%); 43.1% of the isolates were multidrug-resistant (resistant to 3 or more agents). Six (10.4%) DEC isolates produced extended spectrum beta-lactamases and possessed genetic elements (blaCTX-M, blaTEM and ISEcp1) associated with them. CONCLUSION: We speculate that the lack of significant association of DEC with diarrhoea in children in Kuwait compared to countries surrounding the Arabian Gulf Region may be attributable to high environmental and food hygiene due to high disposable income in Kuwait. Language: English Keywords: KUWAIT | RESEARCH REPORT | CONTROL GROUPS | CHILDREN | BACTERIAL AND FUNGAL DISEASES | DIARRHEA | DIARRHEA, INFANTILE | PREVALENCE | ANTIBIOTICS | DRUG RESISTANCE | Middle East | Developed Countries | Research Methodology | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Infections | Diseases | Measurement | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341689 |
| 8. Peer Reviewed Title: Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Author: Allen RH; Fitzmaurice G; Lifford KL; Lasic M; Goldberg AB Source: Obstetrics and Gynecology. 2009 Feb;113(2 Pt 1):276-83. Abstract: OBJECTIVE: To test the equivalency of oral sedation and intravenous sedation for pain control in first-trimester surgical abortion. METHODS: Women undergoing suction curettage at less than 13 weeks of gestation were randomly assigned to oral sedation, 10 mg of oxycodone and 1 mg of lorazepam, or intravenous sedation, 100 micrograms fentanyl and 2 mg midazolam. All patients received 800 mg of preoperative ibuprofen and a 20-mL paracervical block with 1% lidocaine. The primary outcome was intraoperative pain as measured on a 21-point verbal rating scale that had a range from 0 to 100 (0=no pain and 100=worst pain ever) with an equivalence margin for the treatment group comparison of +/-10. RESULTS: Of 130 women, 65 were randomly assigned to oral sedation and 65 to intravenous sedation. The groups differed at baseline by age and preoperative ratings of depression, stress, and anxiety; however, when adjusted for these differences, the primary results were unaffected. Mean intraoperative pain scores, controlling for age and preoperative depression, stress, and anxiety, were 61.2 for oral sedation and 36.3 for intravenous sedation (mean difference 24.9, 95% confidence interval 15.9-33.9). Other findings included no difference in postoperative adverse effects and less satisfaction with pain control with oral sedation compared with intravenous sedation. CONCLUSION: Oral sedation, as studied, is not equivalent to intravenous sedation for pain control during first-trimester surgical abortion. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00337792 LEVEL OF EVIDENCE: I. Language: English Keywords: MASSACHUSETTS | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | EVALUATION INDEXES | KAP SURVEYS | PREGNANT WOMEN | ANESTHESIA | ABORTION | PREGNANCY, FIRST TRIMESTER | CURETTAGE | ADMINISTRATION AND DOSAGE | PAIN | SIDE EFFECTS | SATISFACTION | Developed Countries | United States of America | North America | Americas | Clinical Research | Research Methodology | Studies | Quantitative Evaluation | Evaluation | Surveys | Sampling Studies | Population Characteristics | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Pregnancy | Reproduction | Obstetrical Surgery | Surgery | Drugs | Signs and Symptoms | Diseases | Psychological Factors | Behavior Document Number: 330360 Notification |
| 9. Title: Misoprostol for pregnancy termination in grand multiparous women with three cesarean deliveries. Author: Alsibiani SA Source: International Journal of Gynaecology and Obstetrics. 2009 Apr 3; Abstract: In countries in which women have high parity, pregnancy termination is common in women who have had multiple cesarean deliveries. Although a combination of mifepristone and misoprostol is recommended for late abortion, in Saudi Arabia, mifepristone is not approved or available. There is little information about the safety of misoprostol for the termination of pregnancy or induction of labor in women with scarred uteri and multiple cesarean deliveries. Although there is no recommended dose or mode of administration for misoprostol in patients with scarred uteri and high parity, it is advisable to use a low dose. Misoprostol use in women with scarred uteri can lead to uterine rupture, but few incidences have been reported in the literature. However, caution is advisable. Misoprostol administered orally has a rapid onset of action and increases uterine tone, but contractions are not experienced unless repeated doses are administered. In addition, women usually prefer oral administration. Vaginal administration offers prolonged activity, greatest bioavailability, and a lower incidence of adverse effects. Use of misoprostol for termination of pregnancy in 2 grand multiparous (gravidity N10) women each with 3 previous cesarean deliveries is summarized in Table 1. According to the WHO expert dosage guidelines, the maximum dose was not exceeded in either patient. In patient 1 an intracervical Foley catheter with syntocinon infusion was used to ripen the cervix followed by oral administration of 800 µg of misoprostol. Patient 2 received a single dose of 800 µg of misoprostol vaginally. Favorable results were obtained in both women using a single high dose of misoprostol. The safety of using misoprostol in women with high parity and scarred uteri could not be ascertained from this study. A larger study is needed to confirm the effectiveness and safety of this regimen in patients with high parity who have had more than 2 previous cesarean deliveries. (full-text) Language: English Keywords: SAUDI ARABIA | RESEARCH REPORT | SUMMARY REPORT | CLINICAL RESEARCH | PREGNANT WOMEN | CESAREAN SECTION | ABORTION | MULTIPARITY | MISOPROSTOL | UTERUS | RU-486 | ADMINISTRATION AND DOSAGE | Middle East | Developing Countries | Research Methodology | Population Characteristics | Demographic Factors | Population | Obstetrical Surgery | Surgery | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Parity | Fertility Measurements | Fertility | Population Dynamics | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Genitalia, Female | Genitalia | Urogenital System | Hormone Antagonists | Hormones | Drugs Document Number: 341466 |
| 10. Peer Reviewed Title: Pregnancy and optimal care of HIV-infected patients. Author: Anderson BL; Cu-Uvin S Source: Clinical Infectious Diseases. 2009 Feb 15;48(4):449-55. Abstract: Human immunodeficiency virus (HIV) infection during pregnancy is a condition that requires multidisciplinary care. Care must be rendered that is appropriate for both the mother and the fetus. Prevention of mother-to-child transmission of HIV is of paramount concern. To prevent transmission, universal testing for HIV infection in pregnant women is ideal. In the United States and other developed countries, great strides have been made toward decreasing the risk of HIV transmission to infants to <2% with use of a combination of highly active antiretroviral therapy during the antepartum period and during labor and delivery, scheduled cesarean section when appropriate, avoidance of breast-feeding, and 6 weeks of zidovudine prophylaxis for infants. The continuation of antiretroviral therapy after delivery depends on the needs of the mother with regard to treatment of her own health. In resource-limited countries, where simplified and shortened courses of antiretroviral regimens have been used, reduction in mother-to-child transmission has also been shown, although not as effectively as that with highly active antiretroviral therapy. In these settings, exclusive breast-feeding for 6 months is recommended to reduce the risk of postnatal transmission. Language: English Keywords: UNITED STATES OF AMERICA | DEVELOPING COUNTRIES | RECOMMENDATIONS | PREGNANT WOMEN | PREVENTION OF MOTHER-TO-CHILD TRANSMISSION | HIV TESTING | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | DRUG RESISTANCE | ANTIRETROVIRAL THERAPY | RISK FACTORS | CESAREAN SECTION | BREASTFEEDING | Developed Countries | North America | Americas | Population Characteristics | Demographic Factors | Population | Disease Transmission Control | Prevention and Control | Diseases | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Treatment | Drugs | HIV | HIV Infections | Viral Diseases | Obstetrical Surgery | Surgery | Infant Nutrition | Nutrition Document Number: 342644 |
| 11. Peer Reviewed Title: Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: effects on markers of inflammation and innate immunity in cervicovaginal fluid. Author: Anderson DJ; Williams DL; Ballagh SA; Barnhart K; Creinin MD; Newman DR; Bowman FP; Politch JA; Duerr AC; Jamieson DJ Source: American Journal of Reproductive Immunology. 2009 Feb;61(2):121-9. Abstract: OBJECTIVE: Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense. METHOD OF STUDY: Eighty-one non-pregnant women were randomized into three groups and instructed to use Milex (CooperSurgical, Inc., Trumbull, CT, USA)diaphragms overnight for 14 days in combination with one of the two acid-buffering microbicide gels [ACIDFORM (Instead Inc., La Jolla, CA, USA) or BufferGel(trade mark) (BG; ReProtect Inc., Baltimore, Maryland)] or placebo gel (K-Y Jelly); Personal Products Inc., Raritan, NJ, USA). Cervicovaginal lavages (CVLs) were performed prior to study entry and on days 8 and 16. Nine soluble mediators of vaginal inflammation or immune defense were measured in CVLs by Bio-Plex or ELISA. RESULTS: Use of diaphragms with placebo ormicrobicide gel was not associated with increased levels of inflammation markers. Concentrations of secretory leukocyte protease inhibitor (SLPI) were markedly reduced in the BG group. CONCLUSION: Daily use of a diaphragm with placebo or acidifying microbicide gel did not cause cervicovaginal inflammation. However, diaphragm/BG use was associated with markedly reduced levels of SLPI, an important mediator of innate immune defense. Further studies are warranted to establish the safety of diaphragm/microbicide gel combinations. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | CASE CONTROL STUDIES | MICROBICIDES | VAGINAL GEL | LUBRICANTS | IMMUNITY, NATURAL | CONTRACEPTIVE SAFETY | VAGINAL DIAPHRAGM | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Studies | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Ingredients and Chemicals | Immunity | Immune System | Physiology | Biology | Safety | Public Health | Vaginal Barrier Methods | Barrier Methods Document Number: 330234 |
| 12. Title: Combined oral contraceptive pills for treatment of acne. Author: Arowojolu AO; Gallo MF; Lopez LM; Grimes DA; Garner SE Source: Cochrane Database of Systematic Reviews. 2009;(3):CD004425. Abstract: BACKGROUND: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. OBJECTIVES: To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. SEARCH STRATEGY: We searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placeboor another active therapy for acne in women were eligible. DATA COLLECTION AND ANALYSIS: We extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan. MAIN RESULTS: The search yielded 25 trials: 7 placebo-controlled trials made 4 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found the COC groups were similar. AUTHORS' CONCLUSIONS: The four COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN | ACNE | TREATMENT | ORAL CONTRACEPTIVES, COMBINED | ADMINISTRATION AND DOSAGE | ANTIBIOTICS | HORMONES | Clinical Research | Research Methodology | Studies | Demographic Factors | Population | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Drugs | Endocrine System | Physiology | Biology Document Number: 341912 |
| 13. Peer Reviewed Title: Prevalence of tuberculosis, HIV and respiratory symptoms in two Zambian communities: implications for tuberculosis control in the era of HIV. Author: Ayles H; Schaap A; Nota A; Sismanidis C; Tembwe R; De Haas P; Muyoyeta M; Beyers N Author: Peter Godfrey-Faussett for the ZAMSTAR Study Team Source: PloS One. 2009;4(5):e5602. Abstract: BACKGROUND: The Stop TB Partnership target for tuberculosis is to have reduced the prevalence of tuberculosis by 50% comparing 2015 to 1990. This target is challenging as few prevalence surveys have been conducted, especially in high burden tuberculosis and HIV countries. Current tuberculosis control strategies in high HIV prevalent settings are therefore based on limited epidemiological evidence and more evidence is needed from community-based surveys to inform improved policy formulation. METHODS AND FINDINGS: 8044 adults were sampled from 2 sub-districts (wards) in Lusaka province, Zambia. Questionnaires were used to screen for symptoms, respiratory samples were obtained for culture and oral secretions collected for HIV testing. 79 individuals were found to have Mycobacterium tuberculosis in their sputum, giving an adjusted overall prevalence of tuberculosis of 870/100,000 (95% CI 570-1160/100,000). The adjusted overall prevalence of HIV was 28.61% (95% CI 26.04-31.19). HIV- infection was significantly associated with prevalent tuberculosis (Adj OR 2.3, 95% CI 1.42-3.74) and the population attributable fraction of HIV for prevalent tuberculosis was 36%. Symptoms such as prolonged cough (adj OR 12.72, 95% CI 7.05-22.94) and fever (Adj OR 2.04, 95%CI 1.23-3.39), were associated with prevalent tuberculosis, but 8 (10%) individuals with prevalent tuberculosis denied having any symptoms at all and only 34 (43%) would have been classified as a TB suspect by current guidelines. CONCLUSIONS: Undiagnosed tuberculosis is a challenge for tuberculosis control and new approaches are needed if we are to reach international targets. Epidemiological studies can inform screening algorithms for both detection and prevention of active tuberculosis. Language: English Keywords: ZAMBIA | RESEARCH REPORT | SAMPLING STUDIES | ADULTS | TUBERCULOSIS | HIV INFECTIONS | RESPIRATORY INSUFFICIENCY | PREVALENCE | SCREENING | SIGNS AND SYMPTOMS | LABORATORY EXAMINATIONS AND DIAGNOSES | PREVENTION AND CONTROL | ANTIBIOTICS | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Studies | Research Methodology | Age Factors | Population Characteristics | Demographic Factors | Population | Infections | Diseases | Viral Diseases | Pulmonary Effects | Physiology | Biology | Measurement | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment Document Number: 342445 |
| 14. Peer Reviewed Title: Expanding antiretroviral options in resource-limited settings--a cost-effectiveness analysis. Author: Bendavid E; Wood R; Katzenstein DA; Bayoumi AM; Owens DK Source: Journal of Acquired Immune Deficiency Syndromes. 2009 Sep 1;52(1):106-13. Abstract: BACKGROUND: Current World Health Organization (WHO) guidelines for treatment of HIV in resource-limited settings call for 2 antiretroviral regimens. The effectiveness and cost-effectiveness of increasing the number of antiretroviral regimens is unknown. METHODS: Using a simulation model, we compared the survival and costs of current WHO regimens with two 3-regimen strategies: an initial regimen of 3 nucleoside reverse transcriptase inhibitors followed by the WHO regimens and the WHO regimens followed by a regimen with a second-generation boosted protease inhibitor (2bPI). We evaluated monitoring with CD4 counts only and with both CD4 counts and viral load. We used cost and effectiveness data from Cape Town and tested all assumptions in sensitivity analyses. RESULTS: Over the lifetime of the cohort, 25.6% of individuals failed both WHO regimens by virologic criteria. However, when patients were monitored using CD4 counts alone, only 6.5% were prescribed additional highly active antiretroviral therapy due to missed and delayed detection of failure. The life expectancy gain for individuals who took a 2bPI was 6.7-8.9 months, depending on the monitoring strategy. When CD4 alone was available, adding a regimen with a 2bPI was associated with an incremental cost-effectiveness ratio of $2581 per year of life gained, and when viral load was available, the ratio was $6519 per year of life gained. Strategies with triple-nucleoside reverse transcriptase inhibitor regimens in initial therapy were dominated. Results were sensitive to the price of 2bPIs. CONCLUSIONS: About 1 in 4 individuals who start highly active antiretroviral therapy in sub-Saharan Africa will fail currently recommended regimens. At current prices, adding a regimen with a 2bPI is cost effective for South Africa and other middle-income countries by WHO standards. Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | THEORETICAL MODELS | PERSONS LIVING WITH HIV/AIDS | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | COST EFFECTIVENESS | MONITORING | WHO | IMMUNOLOGICAL EFFECTS | LIFE EXPECTANCY | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | HIV Infections | Viral Diseases | Diseases | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Evaluation Indexes | Quantitative Evaluation | Evaluation | UN | International Agencies | Organizations | Political Factors | Sociocultural Factors | Immunity | Immune System | Physiology | Biology | Length of Life | Mortality | Population Dynamics | Demographic Factors | Population Document Number: 342908 |
| 15. Peer Reviewed Title: Potential acceptability of microbicides in HIV prevention in stable marital relationships in Malawi. Author: Bisika T Source: Journal of Family Planning and Reproductive Health Care. 2009 Apr;35(2):115-7. Abstract: BACKGROUND: The XVII International Conference on AIDS held in Mexico City in August 2008 emphasised the importance of dual prevention using both vaccines and microbicides in the fight against HIV and AIDS. Microbicides are important because they constitute one of the potentially important female-controlled methods of HIV and sexually transmitted infection prevention, especially in Malawi where the use of the female condom has not yet been fully embraced. METHODS: A qualitative study utilising focus group discussions was used to assess the acceptability of the microbicide nonoxynol-9 (N-9) as part of the ongoing Preparatory AIDS Vaccine Evaluation (PAVE) studies. RESULTS: The study observed that men oppose the use of N-9, and that although women consider themselves at risk for HIV they caution against the unintended consequence of altering the vaginal environment with the use of microbicides, which can interfere with the men's preference for dry sex. DISCUSSION AND CONCLUSIONS: Although N-9 did not produce the desired results, these can inform the development of other promising microbicide candidates. The study concludes that it is important to pay attention to how new microbicides are formulated rather than just concentrating solely on an individual product's effectiveness. Language: English Keywords: MALAWI | RESEARCH REPORT | FOCUS GROUPS | CURRENTLY MARRIED | HIV PREVENTION | SEXUALLY TRANSMITTED DISEASE PREVENTION | MICROBICIDES | NONOXYNOL-9 | HUSBAND-WIFE COMPARISONS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Data Collection | Research Methodology | Marital Status | Nuptiality | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Spermicidal Contraceptive Agents | Contraceptive Agents | Contraception | Family Planning | Comparative Studies | Studies Document Number: 341651 |
| 16. Peer Reviewed Title: Twenty or thirty microgram ethinyloestradiol in an oral contraceptive: Does it make a difference in the mind and the daily practice of gynaecologists and general practitioners? Author: Bitzer J; Frey B; von Schonau M; Sabler N; Tschudin S Source: European Journal of Contraception and Reproductive Health Care. 2009 Jun 5;:1-10. Abstract: Objectives Currently, evidence-based guidelines concerning the use of oral contraceptives (OCs) containing either 20 or 30 mug ethinyloestradiol (EE) and the same progestogen, are lacking. We wanted to identify whether Swiss gynaecologists and general practitioners (GPs) have specific criteria on which they base their prescribing habit. Methods Two questionnaires were submitted to 158 physicians. The first one contained a list of possible criteria relevant for decision making and a description of specific clinical situations. The second one concerned actual patients who received either a 20 mug (Yasminelle(R)) or a 30 mug (Yasmin(R)) OC containing the same progestogen drospirenone. Results The most relevant criteria for decision making (in hierarchical order) were family history of venous thromboembolic disease (VTE), headache, smoking, age beyond 35, stability of the menstrual cycle, breast tenderness, body mass index, irregular bleeding and acne. The 20 mug dosage was preferred for women older than 35, those smoking more than 15 cigarettes per day, those with a family history of VTE, and those complaining of breast tenderness or headache. The 30 mug dosage was preferred for patients with a history of irregular bleeding, a family history of osteoporosis, expected poor compliance and acne. Conclusion Swiss gynaecologists and GPs do not preferentially prescribe the lowest possible dosage of EE. They use indirect markers they consider relevant for differential prescribing. For some markers, there is inconsistency, indicating that preferences for 20 mug and 30 mug preparations may be influenced by other factors. Language: English Keywords: SWITZERLAND | RESEARCH REPORT | PHYSICIANS | WOMEN | CLIENTS | DECISION MAKING | TOBACCO USE | HEADACHE | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, SIDE EFFECTS | THROMBOEMBOLISM | AGE FACTORS | ADMINISTRATION AND DOSAGE | Developed Countries | Europe, Central | Europe | Health Personnel | Delivery of Health Care | Health | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Behavior | Signs and Symptoms | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Embolism | Vascular Diseases | Population Characteristics | Drugs | Treatment | Medical Procedures | Medicine | Health Services Document Number: 341601 |
| 17. Title: [Assessment of adherence to antiretroviral drugs in a municipality in southern Brazil] Avaliacao da adesao aos anti-retrovirais em um municipio no Sul do Brasil. Author: Blatt CR; Citadin CB; Souza FG; Mello RS; Galato D Source: Revista Da Sociedade Brasileira De Medicina Tropical. 2009 Mar-Apr;42(2):131-6. Abstract: The aim of this research is to assess predicting factors and adherence levels to antiretrovirals through self-report and the date of drug retrieval. It is a transversal study in which 67 patients were interviewed. Patients who used more than 90% of doses were considered to have complied with the treatment. Results of adherence were: self-reports (72.7%); calculated using dosage forgotten on the last day (70%); in three (76.1%) days; in seven (80.5%) days; and in fifteen (80.5%) days; calculated using the date of drug retrieval in a period of three (53.7%) months; and in six (47.8%) months. Variables significantly associated with adherence were: educational level, living with the family, refer good adherence, positive assessment of the antiretroviral therapy, a diagnosis of an opportunistic disease, NADIR greater than 200 cells/mm(3) and being in first-time treatment. To improve adherence rates individual and collective strategies should be elaborated taking into account factors which have been identified as negatively effecting adherence. Language: Portuguese Keywords: BRAZIL | RESEARCH REPORT | INTERVIEWS | CLIENTS | PERSONS LIVING WITH HIV/AIDS | ANTIRETROVIRAL DRUGS | ANTIRETROVIRAL THERAPY | USER COMPLIANCE | TREATMENT | ADMINISTRATION AND DOSAGE | PROGRAM EFFECTIVENESS | South America, Eastern | South America | Latin America | Americas | Developing Countries | Data Collection | Research Methodology | Program Activities | Programs | Organization and Administration | HIV Infections | Viral Diseases | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV | Behavior | Drugs | Program Evaluation Document Number: 342167 |
| 18. Peer Reviewed Title: Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard gel: a randomized, cross-over, pharmacokinetic study. Author: Brache V; Croxatto H; Kumar N; Sitruk-Ware R; Cochon L; Schiappacasse V; Sivin I; Munoz C; Maguire R; Faundes A Source: Contraception. 2009 Feb;79(2):150-4. Abstract: BACKGROUND: The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner. STUDY DESIGN: This was a randomized, cross-over, pharmacokinetic study including an abstinence arm and an arm in which couples engaged in sexual intercourse between 2 and 4 h after gel application. In each study arm, each woman received a single application of Carra/LNG gel (0.75 mg in 4 mL gel) followed by serial blood samples taken at 0, 1, 2, 4, 8, 24 and 48 h after gel application for LNG measurements. In the intercourse arm, LNG was measured in blood samples taken from the male partner before intercourse and at 4, 8 and 24 h after gel application in the female partner. RESULTS: Time concentration curves for serum LNG levels showed a mean C(max) of 7.8+/-5.5 and 8.3+/-5.7 nmol/L, a mean T(max) of 6.2+/-5.9 and 7.5+/-5.7, and comparable area under the curve for the intercourse and abstinence arm, respectively. Pharmacokinetic parameters presented large variability between subjects, but excellent reproducibility within each subject. LNG was undetectable in 10 out of 12 male partners. CONCLUSION: Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible. Language: English Keywords: DOMINICAN REPUBLIC | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN IN DEVELOPMENT | SEXUAL PARTNERS | SEXUAL INTERCOURSE | PHYSIOLOGY | LEVONORGESTREL | VAGINAL GEL | MICROBICIDES | TIME FACTORS | CONTRACEPTIVE EFFECTIVENESS | EMERGENCY CONTRACEPTION | Developing Countries | Caribbean | Americas | Research Methodology | Economic Development | Economic Factors | Sex Behavior | Behavior | Reproduction | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Vaginal Spermicides | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Dynamics | Demographic Factors | Population Document Number: 331015 |
| 19. Title: Influence of transdermal rotigotine on ovulation suppression by a combined oral contraceptive. Author: Braun M; Elshoff JP; Andreas JO; Muller LI; Horstmann R Source: British Journal of Clinical Pharmacology. 2009 Sep;68(3):386-94. Abstract: AIMS: To assess the influence of the transdermally applied dopamine agonist rotigotine on ovulation suppression by a combined oral contraceptive (0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel) in a randomized, double-blind crossover study in 40 healthy females. METHODS: Treatment A consisted of the combined oral contraceptive for 28 days plus rotigotine for the first 13 days (2 mg (24 h)(-1) on days 1-3, 3 mg (24 h)(-1) maintenance dose thereafter). During treatment B, subjects received matching placebo patches instead of rotigotine. Pharmacodynamic parameters (progesterone, oestradiol, luteinizing hormone, and follicle stimulating hormone serum concentrations), pharmacokinetic parameters for ethinyloestradiol/levonorgestrel and rotigotine, and safety and tolerability of the treatment were assessed. RESULTS: Progesterone serum concentrations remained below 2 ng ml(-1) in all subjects during the luteal phase. Median serum concentrations of all other pharmacodynamic parameters were similar during both treatments. Pharmacokinetic parameters C(max,ss) and AUC(0,24 h)(ss) at steady state were similar with or without co-administration of rotigotine for both ethinyloestradiol and levonorgestrel with geometric mean ratios close to 1 and 90% confidence intervals within the acceptance range of bioequivalence (0.8, 1.25): C(max,ss) 1.05 (0.93, 1.19), AUC(0,24 h)(ss) 1.05 (0.9, 1.22) for ethinyloestradiol; C(max,ss) 1.01 (0.96, 1.06), AUC(0,24 h)(ss) 0.98 (0.95, 1.01) for levonorgestrel. Mean plasma concentrations of unconjugated rotigotine remained stable throughout the patch-on period (day 13). CONCLUSIONS: Concomitant administration of 3 mg (24 h)(-1) transdermal rotigotine had no impact on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive containing 0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel, suggesting that the dopamine agonist does not influence contraception efficacy. Language: English Keywords: SOUTH AFRICA | SUMMARY REPORT | WOMEN | ORAL CONTRACEPTIVES, COMBINED | LEVONORGESTREL | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE SAFETY | TREATMENT | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Drugs | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Safety | Public Health Document Number: 342711 |
| 20. Peer Reviewed Title: Association between efficacy and body weight or body mass index for two low-dose oral contraceptives. Author: Burkman RT; Fisher AC; Wan GJ; Barnowski CE; LaGuardia KD Source: Contraception. 2009 Jun;79(6):424-7. Abstract: BACKGROUND: This analysis investigated the association of oral contraceptive efficacy with body weight and body mass index (BMI) for hypothesis-generating purposes. STUDY DESIGN: Data were from a randomized, parallel-group trial of 180/215/250 mcg of norgestimate (NGM)/25 mcg of ethinyl estradiol (EE) (given to 1671 women) and 1 mg of norethindrone acetate (NETA)/20 mcg of EE (given to 1139 women). Pregnancies were evaluated across BMI deciles and by BMI and body weight dichotomies. A Pearl index was calculated for each treatment group. The relative risk (RR) of pregnancy was calculated with a Cox proportional hazards model. RESULTS: The Pearl index for women who received NGM/EE was 2.36 [95% confidence interval (CI)=1.33-3.40]; for those who received NETA/EE, the Pearl index was 3.29 (95% CI=1.81-4.77). Consistent, weak positive associations between weight and pregnancy risk were found. Overall, for women with a BMI >or=25 kg/m(2) (compared with women with a BMI <25 kg/m(2)), the RR of pregnancy was 1.84 (95% CI=0.98-3.45); that for women who received NGM/EE was 1.39 (95% CI=0.57-3.40), whereas that for women who received NETA/EE was 2.49 (95% CI=1.01-6.13). For women with a body weight >or=70 kg (compared with women with a body weight <70 kg), the RR was 1.25 (95% CI=0.63-2.46); that for women who received NGM/EE was 1.41 (95% CI=0.56-3.54), whereas that for women who received NETA/EE was 1.12 (95% CI=0.40-3.12). CONCLUSION: Women in the higher body weight or BMI category showed a small increase in the risk of pregnancy with these oral contraceptives, but this increase was not statistically significant overall or for either formulation studied. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | WOMEN | CONTRACEPTIVE EFFECTIVENESS | BODY WEIGHT | NORGESTIMATE | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | NORETHINDRONE ACETATE | ADMINISTRATION AND DOSAGE | Developed Countries | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Contraception | Family Planning | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Oral Contraceptives | Contraceptive Methods | Norethindrone | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341104 |
| 21. Peer Reviewed Title: Response to zidovudine/didanosine-containing combination antiretroviral therapy among HIV-1 subtype C-infected adults in Botswana: two-year outcomes from a randomized clinical trial. Author: Bussmann H; Wester CW; Thomas A; Novitsky V; Okezie R; Muzenda T; Gaolathe T; Ndwapi N; Mawoko N; Widenfelt E; Moyo S; Musonda R; Mine M; Makhema J; Moffat H; Essex M; Degruttola V; Marlink RG Source: Journal of Acquired Immune Deficiency Syndromes. 2009 May 1;51(1):37-46. Abstract: BACKGROUND: Numerous national antiretroviral (ARV) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy (cART) have recently commenced in southern Africa, the first of which began in Botswana in January 2002. Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region, as does investigation of the development of drug resistance and the optimal means of sustaining adherence. The "Tshepo" Study is the first large-scale, randomized, clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa. METHODS: The Tshepo Study is a completed, open-labeled, randomized study that enrolled 650 ARV-naive adults between December 2002 and 2004. The study is a 3 x 2 x 2 factorial design comparing the efficacy and tolerability among factors: (1) 3 combinations of nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine (ZDV) + lamivudine (3TC), ZDV + didanosine (ddI), and stavudine (d4T) + 3TC; (2) 2 different nonnucleoside reverse transcriptase inhibitors (NNRTIs): nevirapine and efavirenz; and (3) 2 different adherence strategies: the current national "standard of care" versus an "intensified adherence strategy" incorporating a "community-based directly observed therapy." Study patients were stratified into 2 balanced CD4 T-cell count groups: less than 201 versus 201-350 cells per cubic millimeter with viral load greater than 55,000 copies per milliliter. Following Data Safety Monitoring Board recommendations in April 2006, ZDV/ddI-containing arms were discontinued due to inferiority in primary end point, namely, virologic failure with resistance. We report both overall data and pooled data from patients receiving ZDV/ddI- versus ZDV/3TC- and d4T/3TC-containing cART through April 1, 2006. RESULTS: Four hundred fifty-one females (69.4%) and 199 males with a median age of 33.3 years were enrolled into the study. The median follow-up as of April 1, 2006, was 104 weeks, and loss to follow-up rate at 2 years was 4.1%. The median baseline CD4 T-cell count was 199 cells per cubic millimeter [interquartile ratio (IQR) 136-252], and the median plasma HIV-1 RNA level was 193,500 copies per milliliter (IQR 69-250, 472-500). The proportion of participants with virologic failure and genotypic resistance mutations was 11% in those receiving ZDV/ddI-based cART versus 2% in those receiving either ZDV/3TC- or d4T/3TC-based cART (P = 0.002). The median CD4 T-cell count increase at 1 year was 137 cells per cubic millimeter (IQR 74-223) and 199 cells per cubic millimeter (IQR 112-322) at 2 years with significantly lower gain in the ZDV/ddI arm. At 1 and 2 years, respectively, 92.0% and 88.8% of patients had an undetectable plasma HIV-1 RNA level (< or = 400 copies/mL). Kaplan-Meier survival estimates at 1 and 2 years were 96.6% and 95.4%. One hundred twenty patients (18.2%) had treatment-modifying toxicities, of which the most common were lipodystrophy, anemia, neutropenia, and Stevens-Johnson syndrome. There was a trend toward difference in time to treatment-modifying toxicity by pooled dual-NRTI combination and no difference in death rates. CONCLUSIONS: The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults. ZDV/ddI-containing cART, however, is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART. Language: English Keywords: BOTSWANA | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | PERSONS LIVING WITH HIV/AIDS | ADULTS | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | USER COMPLIANCE | DRUG RESISTANCE | IMMUNOLOGICAL EFFECTS | SIDE EFFECTS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Clinical Research | Research Methodology | Studies | HIV Infections | Viral Diseases | Diseases | Age Factors | Population Characteristics | Demographic Factors | Population | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Behavior | Immunity | Immune System | Physiology | Biology Document Number: 342371 |
| 22. Peer Reviewed Title: Route of administration of contraceptives containing desogestrel/etonorgestrel and insulin sensitivity: a prospective randomized study. Author: Cagnacci A; Ferrari S; Tirelli A; Zanin R; Volpe A Source: Contraception. 2009 Jul;80(1):34-9. Abstract: BACKGROUND: The study was conducted to investigate whether hormonal contraceptives administered via the oral and vaginal route exert a similar effect on insulin sensitivity (SI). STUDY DESIGN: This is a prospective, randomized study performed in the University Hospital. Subjects were healthy lean young women, needing a hormonal contraceptive, randomly allocated to receive for 6 months (a) an oral contraceptive (OC) containing 30 mcg ethinylestradiol (EE)/150 mcg desogestrel (DSG) (high-estrogen group; n=12), (b) an OC containing 20 mcg EE/150 mcg DSG (low-estrogen group; n=12) and (c) a vaginal ring contraceptive releasing, per day, 15 mcg EE/120 mcg etonorgestrel, the active DSG metabolite (n=12). SI and glucose utilization independent of insulin (Sg) were evaluated by the minimal model method. Modifications of total, high-density lipoprotein (HDL) and low-density lipoprotein cholesterol and triglycerides were also evaluated. RESULTS: Sg did not vary with any treatment. SI decreased during OCs (5.74+/-0.49 vs. 3.86+/-0.44; p=.0005), independently of the high/low-estrogen dose. SI did not decrease during vaginal ring use (4.64+/-1.03 vs. 5.25+/-1.36; p=.57; p=.019 vs. oral). Total cholesterol and HDL cholesterol increased (p=.02) during OCs, independently of the dose. Triglycerides increased during both oral (p=.01) and vaginal (p=.032) contraceptive use. CONCLUSIONS: The present data indicate that in contrast to OC use, vaginal contraception with the ring does not deteriorate SI. The vaginal ring may represent an appropriate choice for long-term contraception in women at risk for developing diabetes mellitus or metabolic syndrome. Language: English Keywords: ITALY | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | VAGINAL RING | CONTRACEPTION | ADMINISTRATION AND DOSAGE | DESOGESTREL | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Southern | Europe | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents Document Number: 341584 |
| 23. Peer Reviewed Title: A visual dosing aid for first-line pediatric antiretroviral treatment in resource-poor settings. Author: Callens SF; Westreich D; Kitetele F; Lusiama J; Shabani N; Belhorn T; Colebunders R; Behets F; Van Rie A Source: Journal of Tropical Pediatrics. 2009 Apr;55(2):135-7. Abstract: The visual dosing aid (VDA) was developed to facilitate dosing calculations in response to children's; growth and weight during antiretroviral treatment. The theoretical accuracy of the VDA was assessed using anthropometric data from 55 children receiving care in the USA and 324 children in the Democratic Republic of the Congo. The VDA dose was similar to the WHO recommended dose. A potentially significant relative dosing difference of >or=20% occurred in <3% of children for NVP, AZT and d4T, but was observed in 20% for 3TC, overdosing being more frequent. The VDA compared well with generic pediatric fixed dose combination tablets. Results did not differ between sites. The VDA enables accurate dosing of pediatric ART in distinct populations and could facilitate roll-out of pediatric ART in resource-poor settings. Language: English Keywords: DEMOCRATIC REPUBLIC OF THE CONGO | RESEARCH REPORT | CHILDREN | ANTIRETROVIRAL DRUGS | ANTIRETROVIRAL THERAPY | TREATMENT | ADMINISTRATION AND DOSAGE | BODY WEIGHT | Developing Countries | Africa, Central | Africa, Sub Saharan | Africa | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV | HIV Infections | Viral Diseases | Diseases | Drugs | Physiology | Biology Document Number: 331199 |
| 24. Peer Reviewed Title: A randomized trial to compare two dosing intervals of misoprostol following mifepristone administration in second trimester medical abortion. Author: Chai J; Tang OS; Hong QQ; Chen QF; Cheng LN; Ng E; Ho PC Source: Human Reproduction. 2009 Feb;24(2):320-4. Abstract: BACKGROUND: The conventional timing of misoprostol administration after mifepristone for second trimester medical abortion is 36-48 h, but simultaneous administration, which may make the regimen more convenient, has not been studied. The objective of this randomized comparison study is to compare two intervals of administration of misoprostol after pretreatment with mifepristone for second trimester medical abortion. METHODS: Eligible women with gestational age between 12 and 20 weeks were randomized to receive mifepristone 200 mg orally followed by 600 microg misoprostol vaginally either immediately or 36-38 h later, followed by 400 microg vaginal misoprostol every 3 h for a maximum of four doses. The primary outcome measure was the success rate at 24 h after the start of misoprostol treatment and the secondary outcome measures were the induction-to-abortion interval and the frequency of side effects. RESULTS: There was a significant difference in the success rate at 24 h (36-38 h: 100%; immediate: 91.5%). The median induction-to-abortion interval was significantly shorter in the 36-38 h regimen (4.9 h) compared with the immediate regimen (10 h). Side effects in terms of febrile episodes and chills/rigors were significantly higher in the immediate administration group. CONCLUSIONS: Simultaneous use of mifepristone and misoprostol for second trimester medical abortion is not as effective as the regimen using a 36-38 h dosing interval. Language: English Keywords: CHINA | HONG KONG | RESEARCH REPORT | CLINICAL RESEARCH | PREGNANT WOMEN | WOMEN IN DEVELOPMENT | ABORTION | ADMINISTRATION AND DOSAGE | MISOPROSTOL | RU-486 | PREGNANCY, SECOND TRIMESTER | TIME FACTORS | SIDE EFFECTS | Asia, Eastern | Asia | Developing Countries | Developed Countries | Research Methodology | Population Characteristics | Demographic Factors | Population | Economic Development | Economic Factors | Fertility Control, Postconception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Pregnancy | Reproduction | Population Dynamics Document Number: 331075 Notification |
| 25. Title: Mifepristone plus vaginal misoprostol vs vaginal misoprostol alone for medical abortion in gestation 63 days or less in Nepalese women: a quasi-randomized controlled trial. Author: Chawdhary R; Rana A; Pradhan N Source: Journal of Obstetrics and Gynaecology Research. 2009 Feb;35(1):78-85. Abstract: AIM: To compare the efficacy of mifepristone and vaginal misoprostol with misoprostol alone for pregnancy termination up to 63 days. METHOD: This exploratory study was conducted in the Department of Obstetrics and Gynecology, Tribhuvan University Teaching Hospital, Kathmandu, Nepal as a part of a thesis study for a period of one year from April 2005-2006. After confirming a pregnancy < or =63 days gestation by transvaginal ultrasound, an equal number of women (50) were randomized into (i) group A, women who received 200 mg oral mifepristone (RU 486) on day 1 and vaginal misoprostol 800 microg on day 3; and (ii) group B, women who received vaginal misoprostol (800 microg) on day 1 and 3 (total dose 1600 microg). The primary study outcome measure was complete abortion without surgical intervention making comparisons between these two groups in terms of complete abortion rate, need for manual vacuum aspiration for incomplete abortion and pregnancy continuation after reconfirming the diagnosis on transvaginal ultrasound, besides comparing the side effects/complications. RESULTS: Fewer side effects and a more complete abortion rate (94%) was observed in group A (mifepristone and vaginal misoprostol) in comparison to vaginal misoprostol alone (total dose 1600 microg) giving a complete abortion rate of 86% along with a significant hematocrit drop on follow-up day 10 (P = 0.03) besides having increased duration of bleeding (P = 0.017). CONCLUSION: Mifepristone oral (200 mg) followed by vaginal misoprostol (800 microg) on day 3 provides a better success rate (94%) with fewer complications than vaginal misoprostol 800 microg used on days 1 and 3 for medical abortion of pregnancies up to 63 days. Language: English Keywords: NEPAL | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN IN DEVELOPMENT | PREGNANT WOMEN | RU-486 | MISOPROSTOL | ABORTION | VAGINA | ULTRASONICS | ADMINISTRATION AND DOSAGE | TIME FACTORS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | PREGNANCY, FIRST TRIMESTER | Developing Countries | Asia, Southern | Asia | Clinical Research | Research Methodology | Studies | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Prostaglandins, Synthetic | Prostaglandins | Fertility Control, Postconception | Family Planning | Genitalia, Female | Genitalia | Urogenital System | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment | Population Dynamics | Contraceptive Agents | Contraception | Pregnancy | Reproduction Document Number: 341125 |
| 26. Title: Daily trimethoprim-sulfamethoxazole prophylaxis rapidly induces corresponding resistance among intestinal Escherichia coli of HIV-infected adults in Kenya. Author: Chiller TM; Polyak CS; Brooks JT; Williamson J; Ochieng B; Shi YP; Ouma P; Greene C; Hamel M; Vulule J; Bopp C; Slutsker L; Mintz E Source: Journal of the International Association of Physicians in AIDS Care. 2009 May-Jun;8(3):165-9. Abstract: BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMZ) has been recommended by World Health Organization (WHO) as daily prophylaxis for Africans with AIDS to prevent opportunistic infections. Daily TMP-SMZ may reduce its susceptibility to commensal intestinal Escherichia coli (E coli), increasing the burden of TMP-SMZ-resistant pathogens. METHODS: Participants received either daily TMP-SMZ (CD4 <350 cells/mm(3)) or daily multivitamins (MVIs; CD4 > or =350 cells/mm(3)) for 6 months. Stool was collected at baseline, 2 weeks, 2 months, and 6 months. A random E coli was tested for susceptibility. RESULTS: Baseline prevalence of TMP-SMZ resistance ranged from 71% to 81% and was not different across CD4 strata. At 2 weeks, prevalence of TMP-SMZ-resistant E coli increased significantly from 78% to 98% (P < .001) among persons taking daily TMP-SMZ and did not change among persons taking MVIs. CONCLUSIONS: Daily prophylaxis with TMP-SMZ induced in vivo resistance to the drug after 2 weeks. Empiric therapy for diarrhea with agents other than TMP-SMZ should be considered for HIV-infected persons receiving daily TMP-SMZ prophylaxis. Language: English Keywords: KENYA | RESEARCH REPORT | STATISTICAL STUDIES | PERSONS LIVING WITH HIV/AIDS | ADULTS | BACTERIAL AND FUNGAL DISEASES | ANTIBIOTICS | DRUG RESISTANCE | PREVALENCE | DIARRHEA | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Studies | Research Methodology | HIV Infections | Viral Diseases | Diseases | Age Factors | Population Characteristics | Demographic Factors | Population | Infections | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Measurement Document Number: 342456 |
| 27. Title: Frequency of Mycobacterium bovis as an etiologic agent in extrapulmonary tuberculosis in HIV-positive and -negative Mexican patients. Author: Cicero R; Olivera H; Hernandez-Solis A; Ramirez-Casanova E; Escobar-Gutierrez A Source: European Journal of Clinical Microbiology and Infectious Diseases. 2009 May;28(5):455-60. Abstract: Mycobacterium bovis can be an important etiological agent for extrapulmonary (EP) manifestations of tuberculosis, especially in HIV-infected persons. From January 2000 to December 2003, M. bovis as a cause of EP tuberculosis was investigated at the Pneumonology Service, Hospital General de Mexico, Mexico City. Eighty HIV-positive (HIV+) patients and 83 HIV-negative (HIV-) with EP involvement (ganglionar, genitourinary, meningeal, cutaneous, peritoneal, and pericardial) were analyzed using clinical, immunological, bacteriological, histopathological, and molecular biology methods. Mycobacterium species were identified by hsp65-RFLP analysis and species of M. tuberculosis complex isolates by spoligotyping. M. bovis was present in 6 HIV- cases (7.2%; 3 with lymphadenitis and 3 genitourinary) vs 11 in HIV+ cases (13.75%; 7 with lymphadenitis, 3 genitourinary, and 1 meningeal). Favorable response to retroviral and specific M. bovis chemotherapy was observed. Spoligotyping showed a unique profile in each isolate, 16 belonging to BOV1 lineage and 1 to BOV2 lineage. M. bovis is an significant re-emerging cause of EPTB in Mexico. Consumption of unpasteurized dairy products is the most likely source of transmission. Successful treatment depends on the adequate and opportune identification of the agent responsible. Language: English Keywords: MEXICO | RESEARCH REPORT | PROSPECTIVE STUDIES | CLIENTS | ADULTS | PERSONS LIVING WITH HIV/AIDS | TUBERCULOSIS | BACTERIAL AND FUNGAL DISEASES | ANTIBIOTICS | ADMINISTRATION AND DOSAGE | DRUG RESISTANCE | North America | Americas | Developing Countries | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | Age Factors | Population Characteristics | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Infections | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341794 |
| 28. Title: Chron |