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Study of UC-781 Vaginal Microbicide

2014-08-27 03:52:26 | BioPortfolio

Summary

This study will help determine whether the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use.

Description

Purpose: To assess the safety and acceptability of vaginal use of 0.1% and 0.25% UC-781 gel in sexually active HIV-uninfected women, and their male partners, and sexually abstinent HIV-infected women

Design: Single-center, phase I randomized, double-blind, controlled trial with 14 days of twice-daily product or control gel exposure

Study population: Sexually active, HIV-uninfected women at low-risk for HIV and their male partners; sexually-abstinent HIV-infected women; all age 18-45

Size: 36 sexually active HIV-uninfected women and up to 36 of their male partners; 18 sexually abstinent HIV-infected women

Treatment regimen:

Stage 1: HIV-uninfected, sexually active women and 1 male partner per woman:

12 women assigned to 0.1% UC-781 twice daily x 14 days; 12 women assigned to 0.25% UC-781 twice daily x 14 days; 12 women assigned to control gel twice daily X 14 days.

Stage 2: HIV-infected, abstinent women: 12 assigned to 0.25% UC-781 twice daily x 14 days; 6 assigned to control gel twice daily x 14 days

Study duration: Participant accrual will take 6 months. Each participant will be followed for 14 days in Stage 1 and 21 days in Stage 2. Total study duration will be 9 months.

Study Site: The Hope Clinic of Emory University, Decatur, GA

Primary Objectives:

- To assess the safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually active HIV-uninfected women

- To assess the safety and toxicity of 0.25% UC-781 gel administered intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually abstinent HIV-infected women

Secondary Objectives:

- To assess the acceptability of 0.1% and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days among HIV-uninfected, and the acceptability of 0.25% gel similarly administered to HIV-infected women

- To assess the effect of study product on vaginal microflora of HIV-uninfected and HIV-infected women

- To assess the systemic absorption of 0.1% and 0.25% UC-781 gel when administered intravaginally

- To assess HIV viral load in genital secretions in HIV-infected women during 0.25% UC-781 gel use

- To assess the genotypic resistance patterns of HIV in genital secretions and peripheral blood in HIV-infected women during 0.25% UC-781 gel use

- To assess the acceptability of 0.1% and 0.25% UC-781 gel in male sexual partners of HIV-uninfected women

Primary Endpoints:

The safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered intravaginally twice-daily for 14 days in sexually-active HIV-uninfected women and 0.25% UC-781 gel administered in sexually-abstinent HIV-infected women will be assessed by:

- Macroscopic and/or microscopic evidence of vulvar and/or vaginal epithelium damage, including ulceration, abrasion, severe erythema, and/or severe edema

- Macroscopic and/or microscopic evidence of cervical mucosal damage including ulceration, abrasion, severe erythema, and/or severe edema

- Symptoms of genital irritation, including burning, itching or soreness

- Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause

Secondary Endpoints:

Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and 0.25% UC-781 gel use by HIV-infected women will be assessed by:

- Proportion of participants who at Day 14 visit indicate they would be 'somewhat unlikely' or 'very unlikely' to use 0.1% and 0.25% UC-781 gel during sexual intercourse in the future compared to control gel users

- Reported positive aspects of using 0.1% and 0.25% UC-781 gel compared to control gel users

- Reported negative aspects of using 0.1% and 0.25% UC-781 gel compared to control gel users

Study Design

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

Conditions

HIV Infections

Intervention

topical vaginal application of UC-781 gel

Location

Hope Clinic of Emory University
Decatur
Georgia
United States
30030

Status

Completed

Source

Centers for Disease Control and Prevention

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:52:26-0400

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