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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); HIV Prevention Trials Network; National Institute of Mental Health (NIMH); National Institute on Drug Abuse (NIDA)

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