drugset / Trial / NCT00213031
Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
Phase 2
Completed
165 enrolled
Population Council
Bill and Melinda Gates Foundation · collabCenters for Disease Control and Prevention · collabChiang Rai District Health Office · collabChiang Rai Hospital · collabChiang Rai Municipal Health Office · collabChiang Rai Public Health Office · collabCollaboration (TUC) · collabMinistry of Health, Thailand · collabNat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention-Surveillance & Epidemiology · collabNational Center for Infectious Diseases · collab
RandomizedParallel-groupDouble-blindOther
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.
Timeline
- Start
- 2000-02
- Primary completion
- —
- Completion
- 2001-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carraguard | Other / unclassified | — | Other |