Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
Completed · Phase 3 · Has a placebo group
Conditions studied: HIV, HIV Infections, Acquired Immunodeficiency Syndrome
In brief
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen. In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a \> 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.
Key facts
- Study ID
- NCT01967940
- Run by
- Gilead Sciences
- People needed
- 55
- Starts
- 2013-10-25
- Expected to finish
- 2017-07-31
- Last updated by the study team
- 2018-11-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Midway Immunology and Research center — Ft. Pierce, Florida, United States
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Rowan Tree Medical, P.A. — Wilton Manors, Florida, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
- Salvador B Gautier Hospital - Infectious Diseases Department — Santo Domingo, Dominican Republic
- Instituto Dominicano de Estudio Virologicos - IDEV — Santo Domingo, Dominican Republic
- Regional state budget health agency Krasnoyarsk Regional Center for Prevention and Control of AIDS — Krasnoyarsk, Russia
- Center For Prevention and Treatment of AIDS and Infectious Diseases, Saint Petersburg — Saint Petersburg, Russia
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) — Bangkok, Thailand
- Ramathibodi Hospital, Mahidol University — Bangkok, Thailand
- Siriraj Hospital Department of Preventive and Social Medicine, Faculty of Medicine — Bangkok, Thailand
- Chiang Mai University — Chiang Mai, Thailand
- Khon Kaen University — Khon Kaen, Thailand
- Joint Clinical Research Centre — Kampala, Uganda
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.