Botswana Study of UC-781 Vaginal Microbicide - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 5, 2006

Last Updated Date

January 10, 2007

Start Date ^†

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00385554 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Effects on vaginal microflora
Systemic absorption
Use acceptability in trial populations

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Condition ^†

HIV Infections

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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

Gender

Both

Ages

21 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Dawn K Smith, MD, MS, MPH	+267-390-1696 ext 210	dks0@cdc.gov
Contact: Poloko M Kebaabetswe, PhD	+267-390-1696 ext 264	kebaabetsweP@bw.cdc.gov

Location Countries ^†

United States, Botswana

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00385554

Responsible Party

Secondary IDs ^††

BOTUSA MB05

Study Sponsor ^†

Centers for Disease Control and Prevention

Collaborators ^††

CONRAD

Investigators ^†

Principal Investigator:	Dawn K Smith, MD, MPH	BOTUSA/CDC
Study Director:	Lisa A Grohskopf, MD, MPH	Centers for Disease Control and Prevention
Study Director:	Christine K Mauck, MD, MPH	CONRAD

Information Provided By

Centers for Disease Control and Prevention

Verification Date

October 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.