Clinical trial NCT01565850: D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Keywords: HIV-1
HIV
Treatment-Naive
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir 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.


Eligibility 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-naive: 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. Participants 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.

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
timeFrame: Week 48
measure: Change From Baseline in HIV-1 RNA at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in HIV-1 RNA at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in CD4+ Cell Count at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in CD4+ Cell Count at Week 48
timeFrame: Baseline; Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Beverly Hills
country: United States
facility: AHF Research Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Peter J. Ruane, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Anthony Mills MD, Inc
state: California
city: Newport Beach
country: United States
facility: Orange Coast Medical Group
state: California
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center, East Bay AIDS Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: La Playa Medical Group and Clinical Research
state: California
city: San Francisco
country: United States
facility: Kasier Permanente Medical Center
state: California
city: San Francisco
country: United States
facility: TPMG--Clinical Trials Unit
state: California
city: Denver
country: United States
facility: Apex Research
state: Colorado
city: Denver
country: United States
facility: Denver Infectious Disease Consultants, PLLC
state: Colorado
city: Washington
country: United States
facility: Dupont Circle Physician's Group
state: District of Columbia
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
city: Washington
country: United States
facility: Capital Medical Associates, PC
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Gary J. Richmond,M.D.,P.A.
state: Florida
city: Miami Beach
country: United States
facility: Wohlfeiler, Piperato and Associates, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: IDOCF/ValuhealthMD, LLC
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Comprehensive Research Institute
state: Florida
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Macon
country: United States
facility: Mercer University Mercer Medicine
state: Georgia
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Community Research Initiative (CRI)
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: St. Louis
country: United States
facility: Central West Clinical Research Inc
state: Missouri
city: Manhasset
country: United States
facility: North Shore University Hospital / Division of Infectious Diseases
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Charlotte
country: United States
facility: ID Consultants, P.A.
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbia
country: United States
facility: University of South Carolina School of Medicine Division of Infectious Disease
state: South Carolina
city: Dallas
country: United States
facility: Southwest Infectious Disease Clinical Research Inc
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County Infectious Disease Associates
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, PA
state: Texas
city: Houston
country: United States
facility: Gordon E. Crofoot, MD., PA
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Annandale
country: United States
facility: CARE-ID
state: Virginia
city: Seattle
country: United States
facility: Peter Shalit, M.D.
state: Washington
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
Study officials:
affiliation: Gilead Sciences
name: Moupali Das, MD, MPH
role: STUDY_DIRECTOR
References: