Clinical trial NCT00385554: Botswana Study of UC-781 Vaginal Microbicide
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: Microbicide
HIV prevention
Botswana
Preventing acquisition of HIV infection
HIV Seronegativity
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: CONRAD
First posted: 2006-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Effects on vaginal microflora
measure: Systemic absorption
measure: Use acceptability in trial populations
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
city: Arlington
country: United States
facility: CONRAD
state: Virginia
city: Gaborone and Francistown
country: Botswana
facility: BOTUSA HIV Prevention Research Unit
Study officials:
affiliation: BOTUSA/CDC
name: Dawn K Smith, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: CONRAD
name: Christine K Mauck, MD, MPH
role: STUDY_DIRECTOR
References: