Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
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.
Drug: Carraguard (PC-515)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission|
- Safety (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal flora;
- Compliance: collection of applicators and interview(monthly)
- Acceptability: interview (quarterly)
- Preliminary effectiveness: Swabs taken to test for sexually transmitted infections – gonorrhea, chlamydia, trichomoniasis (monthly) and blood drawn for syphilis and HIV testing (Month 1 and quarterly thereafter).
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||January 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213018
|University of Cape Town, Department of Community Health|
|Cape Town, South Africa, 7925|
|Medical University of Southern Africa|
|Soshanguve, South Africa, 0204|
|Principal Investigator:||Charlotte E. Ellertson, MPA, Ph.D.||Population Council|