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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapivirine (TMC120) vaginal gel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Local and systemic safety and tolerability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeda Rosenberg, ScD | Beijing Immupeutics Medicine Technology Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Projet Ubuzima | Kigali | Rwanda | ||||
| Reproductive Health Research Unit - Sheshisani IPM Clinic |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C481671 | Dapivirine |
| D014622 | Vaginal Creams, Foams, and Jellies |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |
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| Yeoville |
| Johannesburg |
| South Africa |
| Farmovs-Parexel | Bloemfontein | South Africa |
| Kilimanjaro Reproductive Health Program | Moshi | Tanzania |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |