Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
Phase 3
Active, not recruiting
NCT02842086
| Condition | Pre-Exposure Prophylaxis of HIV-1 Infection |
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| Phase | Phase 3 |
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| Sponsor | Gilead Sciences |
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| Status | Active, not recruiting |
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| Enrollment | 5,399 participants |
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| Interventions | F/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo |
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| Start date | Sep 2, 2016 |
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| Completion date | Jan 31, 2019 |
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| Results posted | Mar 17, 2020 |
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Summary
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.
Incidence of HIV-1 Infection Per 100 Person Years (PY)
When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks) · HIV-1 infections per 100 PY
| Descovy (DVY) | 0.160 HIV-1 infections per 100 PY |
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| Truvada (TVD) | 0.342 HIV-1 infections per 100 PY |
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| Rate Ratio | 0.468 (95% CI 0.191–1.149) |
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Open in BENITIONS
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