4 results on '"Ramjee, Gita"'
Search Results
2. Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women.
- Author
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Balkus JE, Richardson BA, Rabe LK, Taha TE, Mgodi N, Kasaro MP, Ramjee G, Hoffman IF, and Abdool Karim SS
- Subjects
- Adult, Africa epidemiology, Female, Follow-Up Studies, Humans, Incidence, Middle Aged, Risk Assessment, Trichomonas Vaginitis epidemiology, Trichomonas Vaginitis immunology, United States epidemiology, Vaginal Smears, Vaginosis, Bacterial epidemiology, Vaginosis, Bacterial immunology, HIV Seronegativity immunology, Trichomonas Vaginitis microbiology, Trichomonas vaginalis isolation & purification, Vagina microbiology, Vaginosis, Bacterial microbiology
- Abstract
Background: The vaginal microbiota may play a role in mediating susceptibility to sexually transmitted infections, including Trichomonas vaginalis (TV)., Methods: Data were analyzed from HIV-1-seronegative women participating in HIV Prevention Trials Network Protocol 035. At quarterly visits for up to 30 months, participants completed structured interviews and specimens were collected for genital tract infection testing. T. vaginalis was detected by saline microscopy. Bacterial vaginosis (BV) was characterized by Gram stain using the Nugent score (BV = 7-10; intermediate = 4-6; normal = 0-3 [reference group]). Cox proportional hazards models stratified by study site were used to assess the association between Nugent score category at the prior quarterly visit and TV acquisition., Results: In this secondary analysis, 2920 participants from Malawi, South Africa, United States, Zambia, and Zimbabwe contributed 16,259 follow-up visits. Bacterial vaginosis was detected at 5680 (35%) visits, and TV was detected at 400 (2.5%) visits. Adjusting for age, marital status, hormonal contraceptive use, unprotected sex in the last week and TV at baseline, intermediate Nugent score, and BV at the prior visit were associated with an increased risk of TV (intermediate score: adjusted hazard ratio [aHR], 1.73; 95% confidence interval [CI], 1.21-2.19; BV: aHR, 2.40; 95% CI, 1.92-3.00). Sensitivity analyses excluding 211 participants with TV at baseline were similar to those from the full study population (intermediate score: aHR, 1.54; 95% CI, 1.10-2.14; BV: aHR, 2.23; 95% CI, 1.75-2.84)., Conclusions: Women with a Nugent score higher than 3 were at an increased risk for acquiring TV. If this relationship is causal, interventions that improve the vaginal microbiota could contribute to reductions in TV incidence.
- Published
- 2014
- Full Text
- View/download PDF
3. Ethical considerations in determining standard of prevention packages for HIV prevention trials: examining PrEP.
- Author
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Haire B, Folayan MO, Hankins C, Sugarman J, McCormack S, Ramjee G, and Warren M
- Subjects
- Adenine administration & dosage, Adenine analogs & derivatives, Community-Based Participatory Research standards, Community-Based Participatory Research trends, Deoxycytidine administration & dosage, Deoxycytidine analogs & derivatives, Drug Therapy, Combination, Emtricitabine, Ethics, Research, Health Services Needs and Demand, Humans, Organophosphonates administration & dosage, Practice Guidelines as Topic, Primary Prevention methods, Research Design, Tenofovir, Treatment Failure, United States, United States Food and Drug Administration, Anti-HIV Agents administration & dosage, Clinical Trials as Topic ethics, Clinical Trials as Topic standards, Community-Based Participatory Research ethics, HIV Infections prevention & control, Primary Prevention ethics
- Abstract
The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks--either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV--expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population., (© 2013 John Wiley & Sons Ltd.)
- Published
- 2013
- Full Text
- View/download PDF
4. Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.
- Author
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Abdool Karim SS, Richardson BA, Ramjee G, Hoffman IF, Chirenje ZM, Taha T, Kapina M, Maslankowski L, Coletti A, Profy A, Moench TR, Piwowar-Manning E, Mâsse B, Hillier SL, and Soto-Torres L
- Subjects
- Acrylic Resins adverse effects, Administration, Intravaginal, Adolescent, Adult, Africa epidemiology, Anti-Infective Agents adverse effects, Blotting, Western, Female, HIV Infections epidemiology, HIV Infections transmission, Humans, Middle Aged, Naphthalenesulfonates adverse effects, Polymers adverse effects, Sexual Behavior, United States epidemiology, Young Adult, Acrylic Resins administration & dosage, Anti-Infective Agents administration & dosage, HIV Infections prevention & control, HIV-1, Naphthalenesulfonates administration & dosage, Polymers administration & dosage
- Abstract
Objective: To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male-to-female HIV transmission., Design: Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open-label no gel arm., Methods: Study participants from Malawi, South Africa, Zambia, Zimbabwe, and the USA were instructed to apply study gel up to 1 h before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up., Results: The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 gel, BufferGel, placebo gel, and no gel arms were 2.70, 4.14, 3.91, and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 gel arm was lower than the placebo gel arm (hazard ratio = 0.7, P = 0.10) and the no gel arm (hazard ratio = 0.67, P = 0.06). HIV incidence rates were similar in the BufferGel and both placebo gel (hazard ratio = 1.10, P = 0.63) and no gel control arms (hazard ratio = 1.05, P = 0.78). HIV incidence was similar in the placebo gel and no gel arms (hazard ratio = 0.97, P = 0.89)., Conclusion: The 0.5% PRO2000 gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the Microbicide Development Programme (MDP) 301 trial have confirmed that 0.5% PRO2000 gel has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were well tolerated.
- Published
- 2011
- Full Text
- View/download PDF
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