A Study of BufferGel in Women

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000927
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

The purpose of this study is to see if it is safe to use BufferGel in the vaginas of women who do not have HIV and who have a low risk of getting HIV.

Many new cases of HIV are the result of heterosexual activity. Condom use is currently the only effective way of preventing the spread of HIV and other sexually transmitted diseases (STDs). However, women, who have a greater risk of getting HIV, are often unable to convince their partner to use a condom. Therefore, it is important to develop methods that prevent the spread of HIV and that are controlled by the woman, such as medicines used in the vagina. BufferGel is known to kill the organisms that cause STDs, including HIV. BufferGel may do this without causing genital irritation and sores as other medicines do. More studies are needed to see if this is true.

Detailed Description

Heterosexual transmission of HIV presently accounts for the vast majority of new HIV infections worldwide. Currently the condom is the only method available that has been shown to be effective against HIV and other sexually transmitted diseases (STDs). However, women who are at the greatest risk for acquiring HIV are often unable to negotiate condom use. Therefore, it is important that effective female-controlled barrier methods, such as topical microbicides, be made available to women. BufferGel has sufficient buffer capacity to acidify twice its own volume in human semen, which inactivates STD pathogens, including HIV. Unlike most other topical microbicides, BufferGel is non-detergent so it should not cause genital irritation and lesions. The safety and acceptability of BufferGel still need to be studied more carefully.

Participants are divided into two cohorts. Cohort IA consists of sexually abstinent women and cohort IB consists of sexually active women. Within each U.S. cohort, participants are assigned to apply BufferGel either once or twice daily. Within each international cohort, all participants apply BufferGel twice daily. Participants apply BufferGel for 14 days. Pelvic examinations are performed at Days 7 and 14.

Study Timeline

• Status Verified: 1999-03
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2007-01-08
• Last Update Posted: 2007-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Mem Hosp of Rhode Island; 🇺🇸 Pawtucket, Rhode Island, United States