Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
Status:
Completed
Trial end date:
2002-01-01
Target enrollment:
Participant gender:
Summary
The primary aims of the study were to assess the safety and acceptability of Carraguard ™
(PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims
were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female
transmission of HIV.
The hypothesis was that Carraguard would cause little or no significant irritation, including
lesions; that women would find Carraguard acceptable. The study was not powered to determine
effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of
the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy
trial.
Phase:
Phase 2
Details
Lead Sponsor:
Population Council
Collaborators:
Bill and Melinda Gates Foundation FHI 360 Medical Research Council, South Africa National Institute of Allergy and Infectious Diseases (NIAID) United States Agency for International Development (USAID) University of Cape Town University of Limpopo