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Sponsored by: |
International Partnership for Microbicides, Inc. |
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Information provided by: | International Partnership for Microbicides, Inc. |
ClinicalTrials.gov Identifier: | NCT00303576 |
Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.
Condition | Intervention | Phase |
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HIV Infections |
Drug: dapivirine (TMC120) vaginal gel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I/II Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women. |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Rwanda | |
Projet Ubuzima | |
Kigali, Rwanda | |
South Africa | |
Farmovs-Parexel | |
Bloemfontein, South Africa | |
South Africa, Johannesburg | |
Reproductive Health Research Unit - Sheshisani IPM Clinic | |
Yeoville, Johannesburg, South Africa | |
Tanzania | |
Kilimanjaro Reproductive Health Program | |
Moshi, Tanzania |
Study Director: | Zeda Rosenberg, ScD | IPM |
Study ID Numbers: | IPM003 |
Study First Received: | March 15, 2006 |
Last Updated: | July 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00303576 |
Health Authority: | South Africa: Medicines Control Council; Tanzania: Food and Drug Authority; Rwanda: Ministry of Health |
HIV-1 HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |