drugset / Trial / NCT00213057
Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand
Phase 1
Completed
110 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 · collabMinistry of Health, Thailand · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted. The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.
Timeline
- Start
- 2001-06
- Primary completion
- —
- Completion
- 2002-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carraguard | Other / unclassified | — | Other |