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Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01095796
First received: March 17, 2010
Last updated: October 15, 2015
Last verified: October 2015
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Purpose
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 efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.
| Condition | Intervention | Phase |
|---|---|---|
| HIV HIV Infections | Drug: Stribild Drug: Atripla Drug: Stribild Placebo Drug: Atripla Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
Secondary Outcome Measures:
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96 [ Time Frame: Week 96 ]
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144 [ Time Frame: Week 144 ]
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192 [ Time Frame: Week 192 ]
- The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 ]
- The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192 [ Time Frame: Baseline; Weeks 48, 96, 144, and 192 ]Change = value of the relevant time point minus the baseline value
- The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
| Enrollment: | 707 |
| Study Start Date: | March 2010 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stribild
Stribild plus placebo to match Atripla
|
Drug: Stribild
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
Drug: Atripla Placebo
Placebo to match Atripla tablet administered orally once daily prior to bedtime
|
|
Active Comparator: Atripla
Atripla plus placebo to match Stribild
|
Drug: Atripla
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime
Drug: Stribild Placebo
Placebo to match Stribild STR administered orally once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 ≥ 5,000 copies/mL
- 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 EFV
- 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 12 weeks 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, EFV, or TDF; or subjects with any known allergies to the excipients of Stribild or Atripla 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095796
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01095796
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Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Spectrum Medical Group | |
| Phoenix, Arizona, United States, 85012 | |
| United States, Arkansas | |
| Health for Life Clinic PLLC | |
| Little Rock, Arkansas, United States, 72207 | |
| United States, California | |
| AHF Research Center | |
| Beverly Hills, California, United States, 90211 | |
| Kaiser Permanente Hospital | |
| Hayward, California, United States, 94545 | |
| Living Hope Clinical Foundation | |
| Long Beach, California, United States, 90813 | |
| Kaiser Permanente | |
| Los Angeles, California, United States, 90027 | |
| Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic | |
| Los Angeles, California, United States, 90028 | |
| UCLA Center for Clinical Aids Research and Education | |
| Los Angeles, California, United States, 90035 | |
| Peter J. Ruane, MD, Inc. | |
| Los Angeles, California, United States, 90036 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Anthony Mills, MD, Inc. | |
| Los Angeles, California, United States, 90069 | |
| Orange Coast Medical Group | |
| Newport Beach, California, United States, 92663 | |
| Alameda County Medical Center | |
| Oakland, California, United States, 94602 | |
| East Bay AIDS Center | |
| Oakland, California, United States, 94609 | |
| Stanford University | |
| Palo Alto, California, United States, 94303 | |
| Kaiser Permanente Medical Group | |
| Sacramento, California, United States, 95825 | |
| La Playa Medical Group and Clinical Research | |
| San Diego, California, United States, 92103 | |
| San Francisco General Hospital, University of California, San Francisco | |
| San Francisco, California, United States, 94110 | |
| Metropolis Medical | |
| San Francisco, California, United States, 94115 | |
| Kaiser Permanente Medical Center, Clinical Trials Unit | |
| San Francisco, California, United States, 94118 | |
| United States, Colorado | |
| Apex Research, LLC | |
| Denver, Colorado, United States, 80209 | |
| United States, Connecticut | |
| Yale University HIV Clinical Trials Program | |
| New Haven, Connecticut, United States, 06033 | |
| The Stamford Hospital | |
| Stamford, Connecticut, United States, 06902 | |
| United States, District of Columbia | |
| Dupont Circle Physicians Group | |
| Washington, District of Columbia, United States, 20009 | |
| Whitman-Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| Capital Medical Associates, PC | |
| Washington, District of Columbia, United States, 20036 | |
| George Washington University Medical Faculty Associates | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Therafirst Medical Center | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Broward Health/Comprehensive Care Center | |
| Fort Lauderdale, Florida, United States, 33311 | |
| Gary J. Richmond, MD, PA | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Midway Immunology and Research Center | |
| Fort Pierce, Florida, United States, 34982 | |
| Wohlfeiler, Piperato and Associates, LLC | |
| Miami Beach, Florida, United States, 33139 | |
| The Kinder Medical Group | |
| Miami, Florida, United States, 33133 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| Idocf/ Valuhealthmd, Llc | |
| Orlando, Florida, United States, 32806 | |
| University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department | |
| Tampa, Florida, United States, 33602 | |
| Infectious Disease Research Institute Inc. | |
| Tampa, Florida, United States, 33614 | |
| St. Joseph's Comprehensive Research Institute | |
| Tampa, Florida, United States, 33615 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Emory University | |
| Atlanta, Georgia, United States, 30308 | |
| Atlanta ID Group, PC | |
| Atlanta, Georgia, United States, 30309 | |
| Infectious Disease Specialists of Atlanta | |
| Decatur, Georgia, United States, 30033 | |
| Mercer University School of Medicine | |
| Macon, Georgia, United States, 31210 | |
| United States, Hawaii | |
| Leahi Hospital | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Ruth M. Rothstein CORE Center | |
| Chicago, Illinois, United States, 60612 | |
| Howard Brown Health Center | |
| Chicago, Illinois, United States, 60613 | |
| United States, Maryland | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Community Research Initiative | |
| Boston, Massachusetts, United States, 02215 | |
| The Research Institute | |
| Springfield, Massachusetts, United States, 01107 | |
| Baystate Infectious Diseases Clinical Research | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Be Well Medical Center | |
| Berkley, Michigan, United States, 48072 | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| Central West Clinical Research | |
| St. Louis, Missouri, United States, 63108 | |
| Southampton Healthcare | |
| St. Louis, Missouri, United States, 63139 | |
| United States, New Jersey | |
| ID Care | |
| Hillsborough, New Jersey, United States, 08844 | |
| Saint Michaels Medical Center | |
| Newark, New Jersey, United States, 07102 | |
| South Jersey Infectious Disease | |
| Somers Point, New Jersey, United States, 08244 | |
| Garden State Infectious Diseases Associates, PA | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| SouthWest CARE Center | |
| Sante Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| Upstate ID Association | |
| Albany, New York, United States, 12208 | |
| Montefiore Medical Center - AIDS Center | |
| Bronx, New York, United States, 10467 | |
| Jacobi Medical Center | |
| Bronx, New York, United States, 31210 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| New York Hospital Queens | |
| Flushing, New York, United States, 11355 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Greiger Clinic | |
| Mount Vernon, New York, United States, 10550 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| Chelsea Village Medical, PC | |
| New York, New York, United States, 10011 | |
| Ricky K. Hsu, MD, PC | |
| New York, New York, United States, 10011 | |
| The Aaron Diamond AIDS Research Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Clinical and Translational Research Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Carolinas Medical Center-Myers Park | |
| Charlotte, North Carolina, United States, 28207 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina University | |
| Greenville, North Carolina, United States, 27834 | |
| Rosedale Infectious Diseases | |
| Huntersville, North Carolina, United States, 28078 | |
| Wake Forest University Health Sciences | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Summa Health System | |
| Akron, Ohio, United States, 44304 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| University of South Carolina | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Texas | |
| Southwest Infectious Disease Clinical Research, Inc. | |
| Dallas, Texas, United States, 75204 | |
| Peabody Health Center | |
| Dallas, Texas, United States, 75215 | |
| Tarrant County Infectious Disease Associates | |
| Fort Worth, Texas, United States, 76104 | |
| Valley AIDS Council | |
| Harlingen, Texas, United States, 78550 | |
| Therapeutic Concepts | |
| Houston, Texas, United States, 77004 | |
| Gordon E. Crofoot MD PA | |
| Houston, Texas, United States, 77098 | |
| Research Access Network | |
| Houston, Texas, United States, 77098 | |
| DCOL Center for Clinical Research | |
| Longview, Texas, United States, 75605 | |
| United States, Virginia | |
| Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID) | |
| Annandale, Virginia, United States, 22003 | |
| United States, Washington | |
| Peter Shalit, MD | |
| Seattle, Washington, United States, 98104 | |
| Rockwood Pulmonary and Critical Care | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Puerto Rico | |
| Instituto de Investigacion Clentifica del Sur | |
| Ponce, Puerto Rico, 00731 | |
| Clinical Research Puerto Rico | |
| San Juan, Puerto Rico, 00909 | |
| HOPE Clinical Research | |
| San Juan, Puerto Rico, 00909 | |
| VA Caribbean Healthcare System | |
| San Juan, Puerto Rico, 00921 | |
| University of Puerto Rico, School of Medicine, Proyecto ACTU | |
| San Juan, Puerto Rico, 00935 | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Martin Rhee, MD | Gilead Sciences |
More Information
Publications:
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01095796 History of Changes |
| Other Study ID Numbers: |
GS-US-236-0102 |
| Study First Received: | March 17, 2010 |
| Results First Received: | September 20, 2012 |
| Last Updated: | October 15, 2015 |
Keywords provided by Gilead Sciences:
|
Treatment Naive HIV 1 Infected |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir |
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on July 14, 2017