Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01565850
First received: March 27, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

This study is to evaluate the efficacy darunavir/cobicistat/emtricitabine/GS-7340 (D/C/F/TAF) single-tablet regimen (STR) versus darunavir (DRV)+cobicistat (COBI)+emtricitabine(FTC)/tenofuvir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Drug: D/C/F/TAF
Drug: DRV
Drug: COBI
Drug: FTC/TDF
Drug: Placebo to match D/C/F/TAF
Drug: Placebo to match DRV
Drug: Placebo to match COBI
Drug: Placebo to match FTC/TDF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: April 2012
Study Completion Date: February 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D/C/F/TAF
Participants will receive D/C/F/TAF STR plus placebo to match DRV+COBI+FTC/TDF.
Drug: D/C/F/TAF
DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg STR administered orally once daily
Drug: Placebo to match DRV
Placebo to match DRV administered orally once daily
Drug: Placebo to match COBI
Placebo to match COBI administered orally once daily
Drug: Placebo to match FTC/TDF
Placebo to match FTC/TDF administered orally once daily
Active Comparator: DRV+COBI+FTC/TDF
Participants will receive DRV+COBI+FTC/TDF plus placebo to match D/C/F/TAF.
Drug: DRV
DRV 2x400 mg tablets administered orally once daily
Other Name: Prezista®
Drug: COBI
COBI 150 mg tablet administered orally once daily
Other Name: GS-9350
Drug: FTC/TDF
FTC 200 mg/TDF 300 mg tablet administered orally once daily
Other Name: Truvada®
Drug: Placebo to match D/C/F/TAF
Placebo to match D/C/F/TAF administered orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (≥ 18 years) males or non-pregnant females
  • Ability to understand and sign a written informed consent form
  • General medical condition which does not interfere with the assessments and the completion of the trial
  • Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
  • CD4+ cell count > 50 cells/µL
  • Treatment Naïve: No prior use of any approved or experimental anti-HIV drug for any length of time
  • Screening genotype report must show sensitivity to DRV, TDF and FTC
  • Normal ECG
  • Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
  • Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL
  • Serum amylase ≤ 5 x ULN
  • Adequate hematologic function
  • Normal thyroid-stimulating hormone (TSH)
  • Females of childbearing potential must have a negative serum pregnancy test
  • 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 drugs
  • Female subjects who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and hormonal failure
  • Female subjects who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level test
  • Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product

Exclusion Criteria:

  • A new AIDS defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface Antigen positive
  • Hepatitis C Antibody positive
  • Proven acute hepatitis in the 30 days prior to study entry
  • Have a history or experiencing decompensated cirrhosis
  • Current alcohol or substance use that potentially interferes with study compliance
  • Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
  • 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
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Female subjects who utilize non-estrogen hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Have an implanted defibrillator or pacemaker
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
  • Participation in any other clinical trial without prior approval is prohibited while participating in this trial
  • Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with darunavir and cobicistat
  • Note: Darunavir is a sulfonamide. Subjects who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and darunavir has been identified in patients participating in Phase 2 and Phase 3 trials.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01565850

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
AHF Research Center
Beverly Hills, California, United States, 90211
Anthony Mills MD, Inc
Los Angeles, California, United States, 90069
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Kaiser Permanente
Los Angeles, California, United States, 90027
Orange Coast Medical Group
Newport Beach, California, United States, 92663
Alta Bates Summit Medical Center, East Bay AIDS Center
Oakland, California, United States, 94609
Stanford University
Palo Alto, California, United States, 94304
Kaiser Permanente Medical Group
Sacramento, California, United States, 95825
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
TPMG--Clinical Trials Unit
San Francisco, California, United States, 94118
United States, Colorado
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States, 80220
United States, District of Columbia
Dupont Circle Physician's Group
Washington, District of Columbia, United States, 20009
Whitman-Walker Health
Washington, District of Columbia, United States, 20009
Capital Medical Associates, PC
Washington, District of Columbia, United States, 20036
United States, Florida
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States, 33316
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
IDOCF/ValuhealthMD, LLC
Orlando, Florida, United States, 32806
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33614
United States, Georgia
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Mercer University Mercer Medicine
Macon, Georgia, United States, 31201
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
United States, Massachusetts
Community Research Initiative (CRI)
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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 Inc
St. Louis, Missouri, United States, 63108
United States, New York
North Shore University Hospital / Division of Infectious Diseases
Manhasset, New York, United States, 11030
Weill Cornell Medical College
New York, New York, United States, 10011
United States, North Carolina
ID Consultants, P.A.
Charlotte, North Carolina, United States, 28209
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
University of South Carolina School of Medicine Division of Infectious Disease
Columbia, South Carolina, United States, 29203
United States, Texas
Southwest Infectious Disease Clinical Research Inc
Dallas, Texas, United States, 75219
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Gordon E. Crofoot, MD., PA
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
CARE-ID
Annandale, Virginia, United States, 22003
United States, Washington
Peter Shalit, M.D.
Seattle, Washington, United States, 98104
Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Huyen Cao, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01565850     History of Changes
Other Study ID Numbers: GS-US-299-0102
Study First Received: March 27, 2012
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment-Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Darunavir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014