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Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Last Updated: 2015-11-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-09-30

Brief Summary

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To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

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Detailed Description

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Conditions

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HIV HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stribild

Group Type EXPERIMENTAL

Stribild

Intervention Type DRUG

Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily

ATV Placebo

Intervention Type DRUG

Placebo to match ATV administered orally once daily

RTV Placebo

Intervention Type DRUG

Placebo to match RTV administered orally once daily

FTC/TDF Placebo

Intervention Type DRUG

Placebo to match FTC/TDF administered orally once daily

ATV/r + FTC/TDF

Group Type ACTIVE_COMPARATOR

ATV

Intervention Type DRUG

Atazanavir 300 mg capsule administered orally once daily

Ritonavir

Intervention Type DRUG

Ritonavir (RTV; /r) 100 mg tablet administered orally once daily

FTC/TDF

Intervention Type DRUG

FTC/TDF 200/300 mg tablet administered orally once daily

Stribild Placebo

Intervention Type DRUG

Placebo to match Stribild administered orally once daily

Interventions

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Stribild

Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily

Intervention Type DRUG

ATV

Atazanavir 300 mg capsule administered orally once daily

Intervention Type DRUG

Ritonavir

Ritonavir (RTV; /r) 100 mg tablet administered orally once daily

Intervention Type DRUG

FTC/TDF

FTC/TDF 200/300 mg tablet administered orally once daily

Intervention Type DRUG

Stribild Placebo

Placebo to match Stribild administered orally once daily

Intervention Type DRUG

ATV Placebo

Placebo to match ATV administered orally once daily

Intervention Type DRUG

RTV Placebo

Placebo to match RTV administered orally once daily

Intervention Type DRUG

FTC/TDF Placebo

Placebo to match FTC/TDF administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Norvir® Truvada

Eligibility Criteria

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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 electrocardiogram (ECG)
* Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)
* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x the upper limit of the normal range (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 acquired immunodeficiency syndrome (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)
* Implanted defibrillator or pacemaker
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject 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
* Medications contraindicated for use with EVG, COBI, FTC, TDF, ATV, or ritonavir or subjects with any known allergies to the excipients of Stribild tablets, Truvada tablets, ATV capsules or ritonavir tablets
* Participation in any other clinical trial without prior approval
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marshall Fordyce, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Spectrum Medical Group

Phoenix, Arizona, United States

Site Status

Health for Life Clinic PLLC

Little Rock, Arkansas, United States

Site Status

AHF Research Center

Beverly Hills, California, United States

Site Status

CSI Clinical Trials, Inc.

Costa Mesa, California, United States

Site Status

Apex Research, LLC

Denver, California, United States

Site Status

Kaiser Permanente Hospital

Hayward, California, United States

Site Status