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D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565850
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE March 29, 2012
Results First Submitted Date  ICMJE March 11, 2016
Results First Posted Date  ICMJE April 11, 2016
Last Update Posted Date April 11, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
The 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, along with study drug discontinuation status.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 24 [ Time Frame: 24 Weeks ]
The primary efficacy endpoint is the percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 24.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
    The 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, along with study drug discontinuation status.
  • Change From Baseline in HIV-1 RNA at Week 24 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in HIV-1 RNA at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • Percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ]
    The percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 48.
  • Change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Weeks 24 and 48 [ Time Frame: 24 & 48 Weeks ]
    The change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Weeks 24 and 48.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
Intervention  ICMJE
  • Drug: D/C/F/TAF
    DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily
  • Drug: DRV
    DRV 800 mg (2 × 400 mg tablets) administered orally once daily
    Other Name: Prezista®
  • Drug: COBI
    COBI 150 mg tablet administered orally once daily
    Other Names:
    • Tybost®
    • GS-9350
  • Drug: FTC/TDF
    FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily
    Other Name: Truvada®
  • Drug: D/C/F/TAF Placebo
    D/C/F/TAF placebo tablet administered orally once daily
  • Drug: DRV Placebo
    DRV placebo tablet administered orally once daily
  • Drug: COBI Placebo
    COBI placebo tablet administered orally once daily
  • Drug: FTC/TDF Placebo
    FTC/TDF placebo tablet administered orally once daily
Study Arms  ICMJE
  • Experimental: D/C/F/TAF
    D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo
    Interventions:
    • Drug: D/C/F/TAF
    • Drug: DRV Placebo
    • Drug: COBI Placebo
    • Drug: FTC/TDF Placebo
  • Active Comparator: DRV+COBI+FTC/TDF
    DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo
    Interventions:
    • Drug: DRV
    • Drug: COBI
    • Drug: FTC/TDF
    • Drug: D/C/F/TAF Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2016)
153
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2012)
150
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565850
Other Study ID Numbers  ICMJE GS-US-299-0102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Moupali Das, MD, MPH Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP