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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Ministry of Health, Thailand CONRAD |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00446979 |
This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Placebo gel Drug: UC 781 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Women and Acceptability in Their Male Partners,Chiang Rai, Thailand |
Enrollment: | 90 |
Study Start Date: | June 2007 |
Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
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1: Experimental
UC 781 0.1% carbomer gel
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Drug: UC 781
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
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2: Experimental
UC 781 0.25% carbomer gel
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Drug: UC 781
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
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3: Placebo Comparator
Placebo vaginal gel
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Drug: Placebo gel
HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for women:
Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
Inclusion Criteria for men:
Exclusion Criteria for women:
History of any male sexual partner other than current partner in past six months
- No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including hematology, liver and kidney function
Exclusion Criteria for men:
Thailand | |
Chiang Rai Health Club | |
Chiang Rai, Thailand, 57000 |
Principal Investigator: | Sara J Whitehead, MD, MPH | Centers for Disease Control and Prevention |
Principal Investigator: | Chitlada Utaipiboon, MD | Thailand MOPH - U.S. CDC Collaboration |
Study ID Numbers: | CDC-NCHHSTP-4744, MOPH 109/2548 |
Study First Received: | March 12, 2007 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00446979 |
Health Authority: | United States: Food and Drug Administration |
Microbicides 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 |