Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive 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: July 5, 2016
Last verified: July 2016

February 20, 2013
July 5, 2016
January 2013
September 2014   (final data collection date for primary outcome measure)
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, 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.
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
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, 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.
  • Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, 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 CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline; Week 96 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
    Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
  • Percent Change From Baseline in Hip BMD at Week 96 [ Time Frame: Baseline; Week 96 ] [ Designated as safety issue: Yes ]
    Hip BMD was assessed by DXA scan.
  • Percent Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
    Spine BMD was assessed by DXA scan.
  • Percent Change From Baseline in Spine BMD at Week 96 [ Time Frame: Baseline; Week 96 ] [ Designated as safety issue: Yes ]
    Spine BMD was assessed by DXA scan.
  • Change From Baseline in Serum Creatinine at Week 48 [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Serum Creatinine at Week 96 [ Time Frame: Baseline; Week 96 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Treatment-emergent Proteinuria Through Week 48 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
    Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
  • Percentage of Participants With Treatment-emergent Proteinuria Through Week 96 [ Time Frame: Up to 96 weeks ] [ Designated as safety issue: Yes ]
    Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
  • Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
    Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
  • Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 [ Time Frame: Baseline; Week 96 ] [ Designated as safety issue: Yes ]
    Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
  • Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48 [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: Yes ]
    Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
  • Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96 [ Time Frame: Baseline; Week 96 ] [ Designated as safety issue: Yes ]
    Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
  • 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 E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive 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 elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; 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, Investigator)
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Drug: E/C/F/TAF
    E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
    Other Name: Genvoya®
  • Drug: E/C/F/TDF
    E/C/F/TDF (150/150/200/300 mg) FDC tablet administered orally once daily
    Other Name: Stribild®
  • Drug: E/C/F/TDF Placebo
    E/C/F/TDF placebo tablet administered orally once daily
  • Drug: E/C/F/TAF Placebo
    E/C/F/TAF placebo tablet administered orally once daily
  • Experimental: E/C/F/TAF
    E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks
    Interventions:
    • Drug: E/C/F/TAF
    • Drug: E/C/F/TDF Placebo
  • Active Comparator: E/C/F/TDF
    E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks
    Interventions:
    • Drug: E/C/F/TDF
    • Drug: E/C/F/TAF Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
872
January 2017
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 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
Both
18 Years and older   (Adult, Senior)
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
Australia,   Austria,   Belgium,   Brazil,   Germany,   Spain,   Switzerland,   Thailand
 
NCT01797445
GS-US-292-0111, 2013-000102-37
Yes
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Moupali Das, MD, MPH Gilead Sciences
Gilead Sciences
July 2016

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