A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Overview
- Phase
- Phase 2
- Intervention
- Stribild
- Conditions
- HIV
- Sponsor
- Gilead Sciences
- Enrollment
- 71
- Locations
- 30
- Primary Endpoint
- The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.
Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
- •No prior use of any approved or experimental anti-HIV drug
- •Normal electrocardiogram (ECG)
- •Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
- •Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- •Adequate hematologic function
- •Cluster determinant 4 (CD4) cell count \> 50 cells/µL
- •Serum amylase ≤ 1.5 x ULN
- •Normal thyroid-stimulating hormone
Exclusion Criteria
- •New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
- •Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
- •Hepatitis B surface antigen positive
- •Hepatitis C antibody positive
- •Participants experiencing cirrhosis
- •Participants experiencing ascites
- •Participants experiencing encephalopathy
- •Females who are breastfeeding
- •Positive serum pregnancy test (for females of childbearing potential)
- •Vaccinated within 90 days of study dosing
Arms & Interventions
Stribild
Intervention: Stribild
Atripla
Intervention: Atripla
Outcomes
Primary Outcomes
The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
Time Frame: Week 24
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.
Secondary Outcomes
- The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48(Week 48)
- Change From Baseline in HIV-1 RNA (log_10 Copies/mL)(Baseline to Weeks 24 and 48)
- Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24(Baseline to Week 24)
- Change From Baseline in CD4 Cell Count at Week 48(Baseline to Week 48)
- The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL(Baseline to Weeks 24 and 48)