BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, Anti-Infective Agents, Local, BufferGel, PRO 2000, Vagina, Risk Factors
Eligibility Criteria
Note: Per the 12/15/06 amendment, all study participants will now enter the Phase IIb study. Inclusion Criteria: HIV uninfected Have had sexual intercourse at least once in the 3 months prior to study entry Able to provide adequate contact information to study officials for purposes of follow-up Exclusion Criteria: History of adverse reaction to latex Nonmedical injection drug use in the 12 months prior to study entry Vaginal intercourse more than an average of two times per day in the 2 weeks prior to study entry Plan to become pregnant in the 30 months after study entry Plan to travel away from the study site for more than 3 consecutive months in the 30 months after study entry Plan to relocate away from the study site in the 30 months after study entry Participation in another clinical trial of a vaginal product Pregnant within 42 days of study entry Have a sexually transmitted disease or other reproductive tract infection diagnosed by study staff Abnormal pelvic exam indicating deep epithelial disruption Condition that, in the opinion of the investigator, may interfere with the study Liver or kidney function abnormality of Grade 3 or higher Blood or blood clotting abnormality of Grade 4 or higher
Sites / Locations
- 3535 Market Street CRS
- University of North Carolina Lilongwe CRS
- College of Med. JHU CRS
- Chatsworth CRS
- Med. Research Council-Hlabisa
- Kamwala Clinic CRS
- Seke South CRS
- Spilhaus CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
No Intervention
1
2
3
4
BufferGel
Pro 2000/5 Gel (P)
Placeo Gel