Trial reportAIDS (London, England)2011
Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.
Trial report in AIDS (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00074425 (Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel), which is not on this map. Cited by 130 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women
Who cites it
130 citing papers in PubMed, 7 syntheses or guidelines pooled it, 233 citations in OpenAlex.
- Review of Impact of Risk Reduction Sessions on Sexual Behaviors in HIV Prevention Trials: Insights from Africa.Archives of sexual behavior · 2025Pooled it
- Topical microbicides for preventing sexually transmitted infections.The Cochrane database of systematic reviews · 2021Pooled it
- The effect of HIV counselling and testing on HIV acquisition in sub-Saharan Africa: a systematic review.Sexually transmitted infections · 2016Pooled it
- Hormonal contraception and the risk of HIV acquisition: an individual participant data meta-analysis.PLoS medicine · 2015Pooled it
- Pooled it
- Vaginal microbicides for reducing the risk of sexual acquisition of HIV infection in women: systematic review and meta-analysis.BMC infectious diseases · 2012Pooled it
- Guideline
- Results of a phase 1, randomized, placebo-controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel.PloS one · 2022Trial
- Perspectives from Young South African and Zimbabwean Women on Attributes of Four (Placebo) Vaginal Microbicide Delivery Forms.AIDS and behavior · 2020Trial
- Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial.Journal of women's health (2002) · 2017Trial
- Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study.International journal of STD & AIDS · 2017Trial
- Uptake of hormonal contraceptives and correlates of uptake in a phase III clinical trial in rural South Western Uganda.Reproductive health · 2017Trial
- Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use: Findings from the Carraguard Phase 3 Trial.AIDS and behavior · 2016Trial
- Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.HIV clinical trials · 2016Trial
- Trial
- A Phase 1 Trial to Assess the Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film.Journal of acquired immune deficiency syndromes (1999) · 2016Trial
- Trial
- Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial.Contraception · 2016Trial
- Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.PloS one · 2015Trial
- Trial
70 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 14 institutions in 5 countries.
Funding
Abstract
objectiveTo determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male-to-female HIV transmission.
designPhase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open-label no gel arm.
methodsStudy 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.
resultsThe 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).
conclusionThe 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.