Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
Status:
Completed
Trial end date:
2001-12-01
Target enrollment:
Participant gender:
Summary
The primary aims of the study were to assess the safety and acceptability of PC-515 when
applied vaginally at least three times weekly for 12 months. Secondary aims were to gather
preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of
HIV, and other STIs.
The hypothesis was that Carraguard would cause little or no significant irritation, including
lesions; and 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
trial.
Phase:
Phase 2
Details
Lead Sponsor:
Population Council
Collaborators:
Bill and Melinda Gates Foundation Centers for Disease Control and Prevention Chiang Rai District Health Office Chiang Rai Hospital Chiang Rai Municipal Health Office Chiang Rai Public Health Office Collaboration (TUC) Ministry of Health, Thailand Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention-Surveillance & Epidemiology National Center for Infectious Diseases