Rationale: The overall rationale for all microbicide trials is to identify products that could be used vaginally or rectally to help reduce the user's risk of HIV infection. These candidates could be formulated in many ways including as gels, suppositories, creams, and vaginal rings. PRO 2000 is an HIV entry inhibitor, which means it's meant to block cellular receptors so that HIV would be unable to attach to and infect target cells.
Study question(s): This study is examining the efficacy and safety of 0.5% PRO 2000/5 gel compared to placebo in preventing vaginally acquired HIV infection. The trial was launched as a multi-arm study that compared 2.0% PRO 2000/5 gel and 0.5% PRO2000/5 gel to placebo. The 2.0% arm was discontinued at the recommendation of the study's Data and Safety Monitoring Board (DSMB). Statistical analysis at the time of the DSMB's review showed that there was no more than a small chance that the high-dose gel would show greater protection than the placebo gel - click here for details (PDF).
Participants: 9,673 HIV-negative women
Countries: South Africa, Tanzania, Uganda, Zambia
Trial sponsors and collaborators: Indevus, UK Department for International Development (DFID), UK Medical Research Council
When were results released? Results were announced November 2009. There was no evidence of benefit.
To learn more visit:
http://www.clinicaltrials.gov/ct/gui/show/NCT00262106?order=5