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| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapivirine (TMC120) vaginal ring | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120). | ||
| Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Luc Van Bortel | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drug Research Unit Gent | Ghent | 9000 | Belgium |
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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 |
| D003274 | Contraceptive Devices, Female |
| ID | Term |
|---|---|
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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| 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 |