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Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel
The purpose of this study is to determine the safety and acceptability of a vaginal microbicide in HIV uninfected sexually active women. Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 200 |
| Completion | 2007-10 |
Conditions
- HIV Infections
- Hepatitis B, Chronic
Interventions
- 1% tenofovir gel
Primary outcomes
- Macroscopic evidence of damage to the cervical, vulvar, or vaginal epithelium, including ulceration and other lesions, severe erythema, or severe edema, related or not related to the study gel or applicator
Countries
United States, India