BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

The majority of HIV infected people worldwide became infected with the virus through heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women from becoming infected with HIV during sexual intercourse with an HIV infected partner. This study will test the safety and effectiveness of these gels.

Key facts

Study ID

NCT00074425

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

3101

Starts

2005-01-01

Expected to finish

2008-09-01

Last updated by the study team

2021-11-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 3535 Market Street CRS — Philadelphia, Pennsylvania, United States
• University of North Carolina Lilongwe CRS — Lilongwe, Central Region, Malawi
• College of Med. JHU CRS — Blantyre, Southern Region, Malawi
• Chatsworth CRS — Chatsworth, KwaZulu-Natal, South Africa
• Med. Research Council-Hlabisa — Durban, KwaZulu-Natal, South Africa
• Kamwala Clinic CRS — Lusaka, Zambia
• Seke South CRS — Chitungwiza, Zimbabwe
• Spilhaus CRS — Harare, Zimbabwe

Full record on ClinicalTrials.gov

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