Clinical Trials/NCT01780506

NCT01780506

Completed

Phase 3

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

Gilead Sciences117 sites in 1 country872 target enrollmentDecember 26, 2012

ConditionsHIV HIV Infections

InterventionsE/C/F/TAF E/C/F/TDF Placebo E/C/F/TDF E/C/F/TAF Placebo

DrugsE/C/F/TAF E/C/F/TDF E/C/F/TDF Placebo E/C/F/TAF Placebo

Overview

Phase: Phase 3
Intervention: E/C/F/TAF
Conditions: HIV
Sponsor: Gilead Sciences
Enrollment: 872
Locations: 117
Primary Endpoint: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

Registry

clinicaltrials.gov

Start Date

December 26, 2012

End Date

September 6, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
•Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
•No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis (PEP), up to 6 months prior to screening
•Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)
•Normal electrocardiogram (ECG)
•Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
•Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
•Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
•Adequate hematologic function
•Serum amylase ≤ 5 × ULN

Exclusion Criteria

•A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
•Hepatitis B surface antigen (HBsAg) positive
•Hepatitis C antibody positive
•Individuals experiencing decompensated cirrhosis
•Females who are breastfeeding
•Positive serum pregnancy test
•Have an implanted defibrillator or pacemaker
•Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
•History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
•Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline

Arms & Interventions

E/C/F/TAF (Double-Blind Phase)

E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks

Intervention: E/C/F/TAF

E/C/F/TAF (Double-Blind Phase)

E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks

Intervention: E/C/F/TDF Placebo

E/C/F/TDF (Double-Blind Phase)

E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks

Intervention: E/C/F/TDF

E/C/F/TDF (Double-Blind Phase)

E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks

Intervention: E/C/F/TAF Placebo

Open-Label Extension Phase

After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country.

Intervention: E/C/F/TAF

Outcomes

Primary Outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

Time Frame: Week 48

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Secondary Outcomes

Percent Change From Baseline in Hip BMD at Week 144(Baseline; Week 144)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144(Weeks 96 and 144)
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144(Weeks 48, 96. and 144)
Change From Baseline in CD4+ Cell Count at Week 48(Baseline; Week 48)
Percent Change From Baseline in Spine BMD at Week 48(Baseline; Week 48)
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144(Baseline; Week 144)
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48(Baseline; Week 48)
Percent Change From Baseline in Spine BMD at Week 96(Baseline; Week 96)
Change From Baseline in Serum Creatinine at Week 48(Baseline; Week 48)
Change From Baseline in CD4+ Cell Count at Week 96(Baseline; Week 96)
Change From Baseline in CD4+ Cell Count at Week 144(Baseline; Week 144)
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48(Baseline; Week 48)
Percent Change From Baseline in Hip BMD at Week 96(Baseline; Week 96)
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96(Baseline; Week 96)
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144(Baseline; Week 144)
Percent Change From Baseline in Spine BMD at Week 144(Baseline; Week 144)
Change From Baseline in Serum Creatinine at Week 96(Baseline; Week 96)
Change From Baseline in Serum Creatinine at Week 144(Baseline; Week 144)
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48(Up to 48 weeks)
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96(Up to 96 weeks)
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144(Up to 144 weeks)
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48(Baseline; Week 48)
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96(Baseline; Week 96)