Phase I Study of Safety and Persistence of UC-781 Vaginal Microbicide

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: UC-781 placebo; Drug: UC-781

• Registration Number: NCT00441909
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time.

Detailed Description

Vaginal microbicides are compounds applied to the inside of the vagina that may protect women against vaginal transmission of HIV and other STIs. This study will evaluate the safety of the vaginal microbicide UC-781. Studies have shown UC-781 to be an effective inhibitor of HIV-1 reverse transcriptase. UC-781 has been tested in animal models and in Phase I and II studies in humans. The results of these studies indicated that cervical tissue was fully protected from different variants of HIV. The purpose of this study is to assess the incidence of epithelial disruption and inflammation in the cervix, vagina, and vulva of healthy HIV uninfected women after a single exposure to UC-781 vaginal gel. This study will compare the results of leaving the microbicide in the vagina for varying lengths of time.

The duration of this study is approximately 35 days. Participants in this study will be randomly assigned to one of eight groups, and all participants will receive a single exposure of UC-781 or placebo gel. There will be five total study visits, including the screening and study entry visits. Screening will occur approximately 10 days prior to the study entry visit. At study entry, a single application of microbicide or placebo gel will be inserted for 0, 2, 4,or 8 hours in the vagina. Length of exposure time will differ, depending on which group a participant has been randomly assigned to. Following vaginal exposure to the microbicide, the microbicide will be rinsed off. Vaginal secretions will be collected to test antiviral activity against HIV and assess the amount of microbicide remaining in the vagina. Visits 3 through 5 occur at approximately 24 to 48 hours, 6 to 8 days, and 25 to 35 days following study entry.

At all visits, participants will be asked to complete a questionnaire and undergo a pelvic exam, STI tests, and vital signs measurements. Blood and urine collection will occur at each visit. On selected visits, a colposcopy will be conducted and participants will be interviewed regarding product acceptability, in addition to other measures. Between selected visits, participants will be asked to maintain sexual abstinence or use condoms.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-02-27
• Study First Submitted QC: 2007-02-27
• Study First Posted: 2007-03-01
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-03
• Last Update Posted: 2009-03-05

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3B	UC-781 placebo	Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 2 hours
2B	UC-781 placebo	Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 4 hours
4B	UC-781 placebo	Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 0 hours
1B	UC-781 placebo	Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 8 hours
3A	UC-781	Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 2 hours
4A	UC-781	Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 0 hours
1A	UC-781	Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 8 hours
2A	UC-781	Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 4 hours

Primary Outcome Measures

Name	Time	Method
Local and systemic safety of a one-time dose of UC-781 0.1 % gel for vaginal use at different durations of exposure in HIV uninfected women	Throughout study

Secondary Outcome Measures

Name	Time	Method
Measurement of vaginal flora characteristics	Throughout study
Changes in vaginal flora characteristics after a timed, single exposure	Throughout study
Persistence of UC-781 0.1% gel following a single application	At 0, 2, 4, or 8 hours post application
Systemic absorption of UC-781 following a single application of 0.1% UC-781 gel	At 0, 2, 4, or 8 hours post application
In vitro anti-HIV activity of cervicovaginal lavage fluid	Throughout study
Product acceptability	Throughout study

Trial Locations

Locations (1)

Magee-Womens Hospital of University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States