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
Фаза 3
Идёт, набор закрыт
NCT02842086
| Заболевание | Pre-Exposure Prophylaxis of HIV-1 Infection |
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| Фаза | Фаза 3 |
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| Спонсор | Gilead Sciences |
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| Статус | Идёт, набор закрыт |
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| Участники | 5,399 участн. |
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| Вмешательство | F/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo |
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| Дата начала | 2.09.2016 |
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| Дата завершения | 31.01.2019 |
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| Публикация результатов | 17.03.2020 |
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Кратко
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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