Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01797445
First received: February 20, 2013
Last updated: January 16, 2015
Last verified: January 2015

February 20, 2013
January 16, 2015
January 2013
September 2014   (final data collection date for primary outcome measure)
The proportion of participants achieving HIV-1 RNA < 50 copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
The proportion of subjects who have HIV-1 RNA < 50 copies/mL [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48
Complete list of historical versions of study NCT01797445 on ClinicalTrials.gov Archive Site
  • Percent change from baseline in hip bone mineral density (BMD) [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in spine BMD [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine at Week 48 [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent proteinuria through Week 48 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent proteinuria through Week 48 will be summarized.
  • Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 and 144 [ Time Frame: Weeks 96 and 144 ] [ Designated as safety issue: No ]
  • Proportion of participants with HIV-1 RNA < 20 copies/mL [ Time Frame: Weeks 48, 96, and 144 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count [ Time Frame: Baseline; Weeks 48, 96, and 144 ] [ Designated as safety issue: No ]
  • Percent change from baseline in hip and spine BMD at Weeks 96 and 144 [ Time Frame: Baseline; Weeks 96 and 144 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine at Weeks 96 and 144 [ Time Frame: Baseline; Weeks 96 and 144 ] [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent proteinuria [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent proteinuria through Weeks 96 and 144 will be summarized.
  • Urine retinol binding protein (RBP) to creatinine ratio [ Time Frame: Weeks 48, 96, and 144 ] [ Designated as safety issue: No ]
  • Urine beta-2-microglobulin to creatinine ratio [ Time Frame: Weeks 48, 96, and 144 ] [ Designated as safety issue: No ]
  • To determine the safety by the percent change from baseline in hip bone mineral density [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    To determine the safety of the two treatment regimens as determined by the percent change from baseline in hip bone mineral density at Week 48
  • To determine the safety determined by the change from baseline in serum creatinine at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    To determine the safety of the two treatment regimens as determined by the change from baseline in serum creatinine at Week 48
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

This study will evaluate the efficacy and safety of a single-tablet regimen (STR) containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment naive adults.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Drug: E/C/F/TAF
    Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) single-tablet regimen administered orally once daily
  • Drug: E/C/F/TDF
    Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg (E/C/F/TDF) single-tablet regimen administered orally once daily
    Other Name: Stribild®
  • Drug: Placebo to match E/C/F/TDF
    Placebo to match E/C/F/TDF administered orally once daily
  • Drug: Placebo to match E/C/F/TAF
    Placebo to match E/C/F/TAF administered orally once daily
  • Experimental: E/C/F/TAF
    E/C/F/TAF plus placebo to match E/C/F/TDF for 144 weeks
    Interventions:
    • Drug: E/C/F/TAF
    • Drug: Placebo to match E/C/F/TDF
  • Active Comparator: E/C/F/TDF
    E/C/F/TDF plus placebo to match E/C/F/TAF for 144 weeks
    Interventions:
    • Drug: E/C/F/TDF
    • Drug: Placebo to match E/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.
 
Active, not recruiting
872
July 2016
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), or post-exposure prophylaxis (PEP) up to 6 months prior to screening
  • Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir DF
  • Normal electrocardiogram (ECG)
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
  • Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Females 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 at screening within the post-menopausal range based on the Central Laboratory reference range
  • Age ≥ 18 years

Exclusion Criteria:

  • A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive
  • Individuals experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
  • History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval
  • Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Dominican Republic,   France,   Italy,   Mexico,   Netherlands,   Portugal,   Puerto Rico,   Sweden,   United Kingdom
 
NCT01797445
GS-US-292-0111, 2013-000102-37
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Moupali Das, MD, MPH Gilead Sciences
Gilead Sciences
January 2015

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