Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 27, 2012
February 27, 2014
April 2012
January 2013   (final data collection date for primary outcome measure)
Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 24.
Complete list of historical versions of study NCT01565850 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Weeks 24 and 48.
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Drug: D/C/F/TAF
    DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg STR administered orally once daily
  • 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
  • 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
  • Experimental: D/C/F/TAF
    Participants will receive D/C/F/TAF STR plus placebo to match DRV+COBI+FTC/TDF.
    Interventions:
    • Drug: D/C/F/TAF
    • Drug: Placebo to match DRV
    • Drug: Placebo to match COBI
    • Drug: Placebo to match FTC/TDF
  • Active Comparator: DRV+COBI+FTC/TDF
    Participants will receive DRV+COBI+FTC/TDF plus placebo to match D/C/F/TAF.
    Interventions:
    • Drug: DRV
    • Drug: COBI
    • Drug: FTC/TDF
    • Drug: Placebo to match D/C/F/TAF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
February 2014
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01565850
GS-US-299-0102
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Huyen Cao, MD Gilead Sciences
Gilead Sciences
February 2014

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