Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV 1 Infected, Antiretroviral Treatment-Naive Adults
This study is to evaluate the safety, efficacy, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) versus E/C/F/tenofovir disoproxil fumarate (TDF; E/C/F/TDF) STR in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.
Acquired Immunodeficiency Syndrome
Drug: Placebo to match E/C/F/TAF
Drug: Placebo to match E/C/F/TDF
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV 1 Infected, Antiretroviral Treatment-Naive Adults|
- Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
- Change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Percentage of participants switching from a cobicistat-boosted darunavir regimen that remain suppressed at Week 48 of the open-label extension phase [ Time Frame: Week 48 ] [ Designated as safety issue: No ]Participants who are actively participating in a Gilead-sponsored trial of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors(NRTIs) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate in the open-label extension phase of E/C/F/TAF.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||January 2016|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Participants will receive E/C/F/TAF plus placebo to match E/C/F/TDF.
Elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/GS-7340 10mg STR administered orally once dailyDrug: Placebo to match E/C/F/TDF
Placebo to match E/C/F/TDF administered orally once daily
Active Comparator: E/C/F/TDF
Participants will receive E/C/F/TDF plus placebo to match E/C/F/TAF.
Elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/ tenofovir disoproxil fumarate 300 mg STR administered orally once dailyDrug: Placebo to match E/C/F/TAF
Placebo to match E/C/F/TAF administered orally once daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497899
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|Study Director:||Devi SenGupta, MD||Gilead Sciences|