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Sponsors and Collaborators: |
Centers for Disease Control and Prevention CONRAD |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00385554 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: UC-781 carbomer gel, 0.1% and 0.25% |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 90 |
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.
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
United States, Georgia | |
Centers for Disease Control and Prevention | |
Atlanta, Georgia, United States, 30333 | |
United States, Virginia | |
CONRAD | |
Arlington, Virginia, United States, 22209 | |
Botswana | |
BOTUSA HIV Prevention Research Unit | |
Gaborone and Francistown, Botswana |
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 |
Study ID Numbers: | CDC-NCHSTP 4885, BOTUSA MB05 |
Study First Received: | October 5, 2006 |
Last Updated: | January 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00385554 |
Health Authority: | United States: Food and Drug Administration; Botswana: Drug Regulatory Unit Ministry of Health |
Microbicide HIV prevention Botswana Preventing acquisition of HIV infection HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |