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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Clinical Research Puerto Rico, San Juan 00909, Puerto Rico
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
AHF Research Center, Beverly Hills, California 90211, United States
Anthony Mills MD, Inc, Los Angeles, California 90069, United States
Kaiser Permanente, Los Angeles, California 90027, United States
Peter J. Ruane, MD, Inc., Los Angeles, California 90036, United States
Orange Coast Medical Group, Newport Beach, California 92663, United States
Alta Bates Summit Medical Center, East Bay AIDS Center, Oakland, California 94609, United States
Stanford University, Palo Alto, California 94304, United States
Kaiser Permanente Medical Group, Sacramento, California 95825, United States
La Playa Medical Group and Clinical Research, San Diego, California 92103, United States
TPMG--Clinical Trials Unit, San Francisco, California 94118, United States
Denver Infectious Disease Consultants, PLLC, Denver, Colorado 80220, United States
Capital Medical Associates, PC, Washington, District of Columbia 20036, United States
Dupont Circle Physician's Group, Washington, District of Columbia 20009, United States
Whitman-Walker Health, Washington, District of Columbia 20009, United States
Gary J. Richmond,M.D.,P.A., Fort Lauderdale, Florida 33316, United States
Wohlfeiler, Piperato and Associates, LLC, Miami Beach, Florida 33139, United States
IDOCF/ValuhealthMD, LLC, Orlando, Florida 32806, United States
Orlando Immunology Center, Orlando, Florida 32803, United States
St. Joseph's Comprehensive Research Institute, Tampa, Florida 33614, United States
Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States
Mercer University Mercer Medicine, Macon, Georgia 31201, United States
Howard Brown Health Center, Chicago, Illinois 60613, United States
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Community Research Initiative (CRI), Boston, Massachusetts 02215, United States
Be Well Medical Center, Berkley, Michigan 48072, United States
Henry Ford Health System, Detroit, Michigan 48202, United States
Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
Central West Clinical Research Inc, St. Louis, Missouri 63108, United States
North Shore University Hospital / Division of Infectious Diseases, Manhasset, New York 11030, United States
Weill Cornell Medical College, New York, New York 10011, United States
ID Consultants, P.A., Charlotte, North Carolina 28209, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
University of South Carolina School of Medicine Division of Infectious Disease, Columbia, South Carolina 29203, United States
Southwest Infectious Disease Clinical Research Inc, Dallas, Texas 75219, United States
Tarrant County Infectious Disease Associates, Fort Worth, Texas 76104, United States
Gordon E. Crofoot, MD., PA, Houston, Texas 77098, United States
Therapeutic Concepts, PA, Houston, Texas 77004, United States
DCOL Center for Clinical Research, Longview, Texas 75605, United States
CARE-ID, Annandale, Virginia 22003, United States
Peter Shalit, M.D., Seattle, Washington 98104, United States