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| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
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The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo vaginal ring | Drug | vaginal ring containing no TMC120 (dapivirine) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of a vaginal ring containing TMC120 (dapivirine) | 7 days | |
| TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Luc Van Bortel | Drug Research Unit, UZ Gent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drug Research Unit, UZ 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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| TMC120 (dapivirine) vaginal ring |
| Drug |
vaginal ring containing 120 mg TMC120 (dapivirine) |
|
| 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 |