Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Phase 3

Completed

Conditions: Acquired Immunodeficiency Syndrome
HIV Infections

Interventions: Drug: NNRTI
Drug: Stribild
Drug: FTC/TDF

Registration Number: NCT01495702

Lead Sponsor: Gilead Sciences

Brief Summary: This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) 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: 439

Inclusion Criteria

Ability to understand and sign a written informed consent form
Be stable on the current formulation(s) of an antiretroviral regimen consisting of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes those who began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs.
Be on the first or second antiretroviral regimen with 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
Adequate hematologic function
Serum amylase ≤ 5 × ULN
Estimated glomerular filtration rate ≥ 70 mL/min
Females of childbearing potential must agree to utilize protocol recommended contraception methods or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants 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 protocol-recommended methods of contraception during heterosexual intercourse or be nonheterosexually active, and practice sexual abstinence from the screening visit.
Age ≥ 18 years

Exclusion Criteria

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 those 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 (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and must not be anticipated to require systemic therapy during the study.
Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
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
NNRTI+FTC/TDF	NNRTI	Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
NNRTI+FTC/TDF	FTC/TDF	Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI 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.
NNRTI+FTC/TDF	Stribild	Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI 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 96	Baseline; Week 96
Change From Baseline in CD4+ Cell Count at Week 48	Baseline; Week 48

Trial Locations

Locations (79): Anthony Mills MD Inc
🇺🇸
Los Angeles, California, United States
Atlanta ID Group, PC
🇺🇸
Atlanta, Georgia, United States
Saint Michael's Medical Center
🇺🇸
Newark, New Jersey, United States
Infectious Disease Specialists of Atlanta
🇺🇸
Decatur, Georgia, United States
Philadelphia FIGHT
🇺🇸
Philadelphia, Pennsylvania, United States
Southwest Infectious Disease Clinical Researach Inc
🇺🇸
Dallas, Texas, United States
Therapeutic Concepts PA
🇺🇸
Houston, Texas, United States
Gordon E. Crofoot MD, PA
🇺🇸
Houston, Texas, United States
Maple Leaf Medical Clinic
🇨🇦
Toronto, Ontario, Canada
Metropolis Medical
🇺🇸
San Francisco, California, United States
The Kinder Medical Group
🇺🇸
Miami, Florida, United States
HIV Program Hennepin County Medical Center
🇺🇸
Minneapolis, Minnesota, United States
The Kansas City Free Health Clinic
🇺🇸
Kansas City, Missouri, United States
Prahran Market Clinic
🇦🇺
South Yarra, Australia
Gary Richmond MD, PA, Inc
🇺🇸
Fort Lauderdale, Florida, United States
Alameda County Medical Center
🇺🇸
Oakland, California, United States
Dupont Circle Physicians Group, P.C.
🇺🇸
Washington, District of Columbia, United States
South Jersey Infectious Disease
🇺🇸
Somers Point, New Jersey, United States
Aaron Diamond AIDS Research Center
🇺🇸
New York, New York, United States
East Sydney Doctors
🇦🇺
Sydney, Australia
Tarrant County Infectious Disease Associates
🇺🇸
Fort Worth, Texas, United States
Midway Immunology and Research
🇺🇸
Fort Pierce, Florida, United States
ValuHealth MD, LLC
🇺🇸
Orlando, Florida, United States
Be Well Medical Center
🇺🇸
Berkley, Michigan, United States
Holdsworth House Medical Practice
🇦🇺
Darlinghurst, Australia
Universitatsklinikum Freiburg
🇩🇪
Freiburg, Germany
Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
AHF Research Center
🇺🇸
Beverly Hills, California, United States
Kaiser Permanente
🇺🇸
San Francisco, California, United States
Pacific Oak Medical Group
🇺🇸
Beverly Hills, California, United States
Peter J. Ruane, MD, Inc.
🇺🇸
Los Angeles, California, United States
OASIS Clinic
🇺🇸
Los Angeles, California, United States
La Playa Medical Group and Clinical Research
🇺🇸
San Diego, California, United States
Health Positive
🇺🇸
Safety Harbor, Florida, United States
ID Care
🇺🇸
Hillsborough, New Jersey, United States
ID Consultants, P.A.
🇺🇸
Charlotte, North Carolina, United States
CHU de Besancon - Hopital Saint-Jacques
🇫🇷
Besancon, France
Clinical Alliance for Research & Education - Infectious Disease
🇺🇸
Annandale, Virginia, United States
SEAMEO Regional Centre for Tropical Medicine
🇧🇪
Antwerpen, Belgium
Clinique Medicale Du Quartier Latin
🇨🇦
Montreal, Quebec, Canada
University Hospital of Leuven
🇧🇪
Leuven, Belgium
Groupe Hospitalier Pellegrin
🇫🇷
Bordeaux, France
Hopital Saint Louis
🇫🇷
Paris, France
Hopital Bichat Claude Bernard
🇫🇷
Paris, France
Hopital Saint Antoine
🇫🇷
Paris, France
Medizinische Universitätsklinik
🇩🇪
Bonn, Germany
EPIMED GmbH
🇩🇪
Berlin, Germany
MIB Dienstleistung GmbH
🇩🇪
Berlin, Germany
Infektiologikum
🇩🇪
Frankfurt, Germany
ICH Study Center
🇩🇪
Hamburg, Germany
MUC Research GmbH
🇩🇪
München, Germany
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹
Milano, Italy
Azienda Ospedaliera Ospedale di Circolo Busto Arsizio
🇮🇹
Busto Arsizio/Varese, Italy
Ospedale Luigi Sacco
🇮🇹
Milano, Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
🇮🇹
Roma, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹
Rome, Italy
Hospital de Santa Maria - CHLN EPE
🇵🇹
Lisboa, Portugal
Clinical Research Puerto Rico Inc
🇵🇷
San Juan, Puerto Rico
Hospital de la Santa Creu i Sant Pau
🇪🇸
Barcelona, Cataluña, Spain
Hospital Clinico Universitario de Santiago
🇪🇸
Santiago de Compostela, Galicia, Spain
Hospital del Mar
🇪🇸
Barcelona, Spain
Hospital La Fe de Valencia
🇪🇸
Valencia, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸
Madrid, Spain
Brighton and Sussex University Hospitals NHS Trust
🇬🇧
Brighton, United Kingdom
South London Healthcare NHS Trust
🇬🇧
London, United Kingdom
Western General Hospital
🇬🇧
Edinburgh, United Kingdom
Homerton University Hospital
🇬🇧
London, United Kingdom
St. Thomas' Hospital
🇬🇧
London, United Kingdom
Chelsea & Westminster Hospital
🇬🇧
London, United Kingdom
Kaiser Permanente Medical Group
🇺🇸
Sacramento, California, United States
Sunnybrook Health Sciences Center
🇨🇦
Toronto, Ontario, Canada
Medical University of Vienna
🇦🇹
Wien, Austria
Otto Wagner Spital
🇦🇹
Wien, Austria
Hôpitaux IRIS Sud
🇧🇪
Bruxelles, Belgium
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
Capital Medical Associates, P.C.
🇺🇸
Washington, District of Columbia, United States
Infectious Diseases Associates of Northwest Florida
🇺🇸
Pensacola, Florida, United States
Greiger Clinic
🇺🇸
Mt. Vernon, New York, United States