Botswana Study of UC-781 Vaginal Microbicide

HIV Infections Clinical Trial

Official title:

Phase I Trial of the Safety, Toxicity, and Acceptability of the Microbicide UC-781 When Topically Applied by HIV-uninfected Women and Men in Botswana

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00385554
• Other study ID #: CDC-NCHSTP 4885
• Secondary ID: BOTUSA MB05
• Status: Withdrawn
• Phase: Phase 1
• First received: October 5, 2006
• Last updated: August 15, 2012

Study information

• Verified date: August 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBotswana: Drug Regulatory Unit Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.

Description:

45 women and 45 men, all healthy and sexually active, 21-45 years old, without HIV infection, will be enrolled in Francistown and Gaborone, Botswana. Volunteers will be randomized to receive either 0.1% or 0.25% UC-781 carbomer gel or placebo gel (3 arms. Women will be instructed to apply gel intravaginally, morning and evening, and prior to sex (always with male condom use) for 14 consecutive days. Men will be instructed to apply gel topically for 14 consecutive nights, before bed, allow to dry overnight, and wash it off in the morning. Additionally instructed never to use gel during sex but always to use condoms. Volunteers will be seen weekly for evaluation of symptoms, laboratory toxicities, genital exam findings (with colposcopy for women, and plasma drug levels. Acceptability will be assessed in focus groups in the month after completing gel use.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• 21-45 years old

• citizen of Botswana

• willing to use condoms for 14 days

• PAP smear (normal, inflammation, ASCUS)

• regular menses or amenorrhea

• lives within 1 hour of a study clinic

• pass comprehension test

• provide written informed consent

Exclusion Criteria:

• genital mucosal disruption at screening

• genital surgery within past 8 weeks

• pregnant within past 8 weeks

• currently breastfeeding

• prior hysterectomy

• plans to move within 2 months

• ALT, AST, total bilirubin, or creatinine Grade 2 or above

• Prothrombin or partial thromboplastin time Grade 2 or above

• In other drug/vaccine safety trial

• Has more than one sexual partner in past month

• Unwilling/unsure they can have sex at least twice weekly for 2 weeks

• Any other condition that investigator believes will interfere with the evaluation of study objectives

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• UC-781 carbomer gel, 0.1% and 0.25%

Locations

Country	Name	City	State
Botswana	BOTUSA HIV Prevention Research Unit	Gaborone and Francistown
United States	CONRAD	Arlington	Virginia
United States	Centers for Disease Control and Prevention	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	CONRAD

Countries where clinical trial is conducted

United States,  Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and toxicity of 0.1% and 0.25% UC-781 carbomer gel compared to placebo gel in HIV uninfected, sexually active women and men
Secondary	Effects on vaginal microflora
Secondary	Systemic absorption
Secondary	Use acceptability in trial populations