Status:
COMPLETED
BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Accessible, usable, and effective vaginal microbicides could significantly decrease the spread of HIV. Vaginal microbicides could be used with condoms to prevent HIV infection; they could also be used...
Eligibility Criteria
Inclusion
- Note: Per the 12/15/06 amendment, all study participants will now enter the Phase IIb study.
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
3101 Patients enrolled
Trial Details
Trial ID
NCT00074425
Start Date
January 1 2005
End Date
September 1 2008
Last Update
November 8 2021
Active Locations (8)
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1
3535 Market Street CRS
Philadelphia, Pennsylvania, United States
2
University of North Carolina Lilongwe CRS
Lilongwe, Central Region, Malawi
3
College of Med. JHU CRS
Blantyre, Southern Region, Malawi
4
Chatsworth CRS
Chatsworth, KwaZulu-Natal, South Africa