Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
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.
Drug: Carraguard (PC-515)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Educational/Counseling/Training
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of PC-515 (Lambda Carrageenan) for Vaginal Use as a Possible Microbicide|
- Safety: Genital exam & interview for symptoms after 14 days & monthly thereafter; colposcopy done throughout trial at clinicians' discretion; monthly testing to detect changes in vagina flora.
- Compliance: collection of applicators and interview(monthly)
- Acceptability: interview (quarterly)
- Preliminary effectiveness: Swabs taken to test for sexually transmitted infections – gonorrhea, chlamydia, trichomoniasis and for genital ulcer disease, if ulceration was detected; blood drawn for syphilis and HIV testing and for HSV-2 Pap smear to det
|Study Start Date:||February 2000|
|Estimated Study Completion Date:||December 2001|
Carraguard™ (PC-515), the Population Council’s lead candidate microbicide, was tested in a triple-masked, randomized, placebo-controlled trial fielded in one site in Chiang Rai, northern Thailand. The primary aims of the study were to assess Carraguard’s safety (toxicity) – including signs of local irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings – when applied vaginally for 12 months; to evaluate acceptability; to assess feasibility of conducting a large scale microbicide trial in a non-sex worker population; to gauge women’s reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.
Secondary aims were to investigate HIV infections averted (preliminary indications); other sexually transmitted infections averted – including C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications); and effect on cervical cytology.
|Chiang Rai Health Club|
|Chiang Rai, Thailand, 57001|
|Principal Investigator:||Janneke HMM van de Wijgert, Ph.D.||Population Council|