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Study was transferred to partner who will conduct under its own IND
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.
The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Matrix Ring | Experimental | Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month. |
|
| Oral Emtricitanbine/Tenofovir Disoproxil | Experimental | Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapivirine | Drug | Silicone elastomer vaginal matrix ring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by grade 2 or higher adverse event. | To compare the safety profiles of FTC/TDF oral tablet administered daily and dapivirine vaginal matrix ring (25 mg) inserted for use of each study product in an adolescent and young adult female population | 12 months |
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Exclusion Criteria:
Inclusion Criteria:
Adolescent and young adult female
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| Name | Affiliation | Role |
|---|---|---|
| Dianne M Rausch, PHD | US National Institutes of Health (NIH) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAPRISA, eThekwini Clinical Research Site | Durban | KwaZulu-Natal | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38852114 | Derived | Ngure K, Browne EN, Reddy K, Friedland BA, van der Straten A, Palanee-Phillips T, Nakalega R, Gati B, Kalule HN, Siziba B, Soto-Torres L, Nair G, Garcia M, Celum C, Roberts ST. Correlates of Adherence to Oral and Vaginal Pre-exposure Prophylaxis (PrEP) Among Adolescent Girls and Young Women (AGYW) Participating in the MTN-034/REACH Trial. AIDS Behav. 2024 Sep;28(9):2990-3000. doi: 10.1007/s10461-024-04382-3. Epub 2024 Jun 9. |
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| ID | Term |
|---|---|
| C481671 | Dapivirine |
| D003274 | Contraceptive Devices, Female |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
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Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial
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| Truvada | Drug | Tablets to be taken orally daily |
|
|
| D009943 |
| Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |