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

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.

Conditions

• HIV Infections

Interventions

DRUG

BufferGel

Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of BufferGel intravaginally up to 60 minutes before each vaginal intercourse while in the study.

DRUG

PRO 2000/5 Gel

Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.

DRUG

Placebo gel

Participants will be given single-use, prefilled applicators of gel and will be instructed to apply one dose of PRO 2000/5 Gel intravaginally up to 60 minutes before each vaginal intercourse while in the study.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• HIV Prevention Trials Network

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Salim Abdool Karim, MBChB, PhD · University of KwaZulu-Natal, Centre for the AIDS Programme of Research in South Africa, Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine

• Irving Hoffman, PA, MPH · School of Medicine, University of North Carolina

• Lisa Maslankowski, MD · University of Pennsylvania

• Groesbeck Parham, MD · Centre for Infectious Disease Research in Zambia

• Nancy Padian, PhD · Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco; AIDS Research Institute

• Gita Ramjee, PhD · Medical Research Council, HIV Prevention Research Unit

• Taha Taha, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2008-09-30

Completion

2008-09-30

Countries

• United States
• Malawi
• South Africa
• Zambia
• Zimbabwe

Study Locations