Botswana Study of UC-781 Vaginal Microbicide
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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 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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 |
- 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
- Effects on vaginal microflora
- Systemic absorption
- Use acceptability in trial populations
Enrollment: | 0 |
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.
![](https://webarchive.library.unt.edu/web/20130315212828im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
![](https://webarchive.library.unt.edu/web/20130315212828im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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: | Christine K Mauck, MD, MPH | CONRAD |
![](https://webarchive.library.unt.edu/web/20130315212828im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00385554 History of Changes |
Other Study ID Numbers: | CDC-NCHSTP 4885, BOTUSA MB05 |
Study First Received: | October 5, 2006 |
Last Updated: | August 15, 2012 |
Health Authority: | United States: Food and Drug Administration Botswana: Drug Regulatory Unit Ministry of Health |
Keywords provided by Centers for Disease Control and Prevention:
Microbicide HIV prevention Botswana Preventing acquisition of HIV infection HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 14, 2013