Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Phase 3

Completed

Conditions: HIV Infections
Acquired Immunodeficiency Syndrome

Interventions: Drug: PI
Drug: RTV
Drug: FTC/TDF
Drug: Stribild

Registration Number: NCT01475838

Lead Sponsor: Gilead Sciences

Brief Summary: This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 438

Inclusion Criteria

Ability to understand and sign a written informed consent form
Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit
Be on the first or second antiretroviral drug regimen documented undetectable plasma HIV 1 RNA levels for ≥ 6 months preceding the screening visit
No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time
Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC
HIV RNA < 50 copies/mL at screening
Normal ECG
Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 × ULN
Estimated glomerular filtration rate ≥ 70 mL/min
Females of childbearing potential must agree to utilize highly effective contraception methods, or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
Female participants who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
Male participants must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product, or must be nonheterosexually active, or practice sexual abstinence
Age ≥ 18 years

Exclusion Criteria

A new AIDS-defining condition diagnosed within the 30 days prior to screening
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Receiving drug treatment for hepatitis C, or participants who are anticipated to receive treatment for hepatitis C during the course of the study
Experiencing decompensated cirrhosis
Have an implanted defibrillator or pacemaker
Current alcohol or substance abuse that would interfere with compliance
A 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 requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis
Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
Receiving ongoing therapy with any of the medications, including drugs not to be used with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the excipients of E/C/F/TDF tablets, or FTC/TDF tablets
No anticipated need to initiate drugs during the study that are contraindicated
Receiving other investigational drugs
Participation in any other clinical trial
Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PI+RTV+FTC/TDF	Stribild	Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
PI+RTV+FTC/TDF	PI	Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
Stribild	Stribild	Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.
PI+RTV+FTC/TDF	FTC/TDF	Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
PI+RTV+FTC/TDF	RTV	Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	Week 48	The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	Week 96	The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Change From Baseline in CD4+ Cell Count at Week 48	Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96	Baseline; Week 96

Trial Locations

Locations (97): Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
Pueblo Family Physicians
🇺🇸
Phoenix, Arizona, United States
AIDS Healthcare Foundation
🇺🇸
Beverly Hills, California, United States
Pacific Oaks Medical Group
🇺🇸
Beverly Hills, California, United States
Kaiser Permanente
🇺🇸
Sacramento, California, United States
Peter J. Ruane, M.D., Inc.
🇺🇸
Los Angeles, California, United States
OASIS Clinic
🇺🇸
Los Angeles, California, United States
Anthony Mills MD Inc
🇺🇸
Los Angeles, California, United States
Stanford University
🇺🇸
Palo Alto, California, United States
University of California, Davis
🇺🇸
Sacramento, California, United States
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Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States