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

HIV Infections Clinical Trial

Official title: Phase I Study of the Safety and Persistence of 0.1% UC-781 Vaginal Gel in HIV-1 Seronegative Women

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT00441909
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: April 2006
• Completion date: April 2008