Safety and Tolerability of the Vaginal Gel PRO 2000/5

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00006207
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes irritation when used daily.

Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active. However, it was not determined what side effects to skin in the vaginal area there might be in sexually active women.

Detailed Description

Vaginal microbicides are designed to inhibit the sexual transmission of HIV-1 and other disease pathogens. Two Phase I clinical trials were conducted to evaluate the safety and tolerance of the gel, PRO 2000/5, in sexually abstinent volunteers. Both demonstrated that multiple application of the gel was safe and well tolerated in healthy, sexually abstinent women but no clear association between the use of the gel and epithelial disruption was indicated. Because genital ulceration and inflammation may increase the risk of HIV infection, additional clinical evaluation of PRO 2000/5 gel is warranted, especially for study participants with active sexual behavior.

Participants apply PRO 2000/5 gel intravaginally either once or twice daily for 14 days. HIV-negative participants in sexually active cohorts (Cohorts A1-A4) are instructed to engage in vaginal intercourse at least twice a week. Participants in the HIV-positive cohort (Cohort B1) abstain from sexual intercourse for the dosing period. Researchers conduct physical exams to see if the gel is having any harmful effects on the woman's vulva, vagina, or cervix. Women and their male partners are questioned about gel usage.

Study Timeline

• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2003-06
• Last Update Submitted: 2008-07-29
• Last Update Posted: 2008-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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)

Julia Welch; 🇺🇸 Research Triangle Park, North Carolina, United States