drugset / Trial / NCT00213018
Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
Phase 2
Completed
400 enrolled
Population Council
Bill and Melinda Gates Foundation · collabFHI 360 · collabMedical Research Council, South Africa · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabUnited States Agency for International Development (USAID) · collabUniversity of Cape Town · collabUniversity of Limpopo · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 1999-10
- Primary completion
- —
- Completion
- 2002-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carraguard | Other / unclassified | — | Other |