Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Phase 3

Completed

Interventions: Drug: COBI
Drug: RTV
Drug: ATV
Drug: FTC/TDF
Drug: COBI placebo
Drug: RTV placebo

Brief Summary: The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.

Recruitment & Eligibility

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 ≥ 5,000 copies/mL at screening
No prior use of any approved or investigational antiretroviral drug for any length of time
Screening genotype report must show sensitivity to FTC, TDF and ATV
Normal ECG
Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 x ULN
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
Age ≥ 18 years
Life expectancy ≥ 1 year

Exclusion Criteria

A new AIDS-defining condition diagnosed within the 30 days prior to screening
Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
Subjects experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Have an implanted defibrillator or pacemaker
Have an ECG PR interval ≥ 220 msec
Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline.
Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

Arm && Interventions

Group	Intervention	Description
ATV+COBI+FTC/TDF	ATV	COBI + RTV placebo + ATV + FTC/TDF once daily
ATV+RTV+FTC/TDF	ATV	RTV + COBI placebo + ATV + FTC/TDF once daily
ATV+RTV+FTC/TDF	FTC/TDF	RTV + COBI placebo + ATV + FTC/TDF once daily
ATV+RTV+FTC/TDF	COBI placebo	RTV + COBI placebo + ATV + FTC/TDF once daily
ATV+COBI+FTC/TDF	FTC/TDF	COBI + RTV placebo + ATV + FTC/TDF once daily
ATV+COBI+FTC/TDF	RTV placebo	COBI + RTV placebo + ATV + FTC/TDF once daily
ATV+COBI+FTC/TDF	COBI	COBI + RTV placebo + ATV + FTC/TDF once daily
ATV+RTV+FTC/TDF	RTV	RTV + COBI placebo + ATV + FTC/TDF once daily

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	Week 48	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in CD4 Cell Count at Week 96	Baseline to Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144	Week 144	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Change From Baseline in CD4 Cell Count at Week 48	Baseline to Week 48
Change From Baseline in CD4 Cell Count at Week 144	Baseline to Week 144
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	Week 96	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192	Week 192	The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Change From Baseline in CD4 Cell Count at Week 192	Baseline to Week 192

Locations (134): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
Health for Life Clinic PLLC
🇺🇸
Little Rock, Arkansas, United States
Living Hope Clinical Foundation
🇺🇸
Long Beach, California, United States
Kaiser Permanente
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Los Angeles, California, United States
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
🇺🇸
Los Angeles, California, United States
Peter J Ruane, MD, Inc
🇺🇸
Los Angeles, California, United States
Oasis Clinic
🇺🇸
Los Angeles, California, United States
Anthony Mills MD Inc
🇺🇸
Los Angeles, California, United States
University of California, Davis Medical Center
🇺🇸
Sacramento, California, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States