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Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01497899
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : January 8, 2016
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE December 14, 2011
First Posted Date  ICMJE December 23, 2011
Results First Submitted Date  ICMJE December 4, 2015
Results First Posted Date  ICMJE January 8, 2016
Last Update Posted Date November 19, 2018
Actual Study Start Date  ICMJE December 28, 2011
Actual Primary Completion Date October 17, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
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: December 4, 2015)
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
    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.
  • Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48 [ Time Frame: Baseline; Weeks 24 and 48 ]
  • Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 [ Time Frame: Baseline; Weeks 24 and 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Official Title  ICMJE A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Brief Summary The primary objective of this study is to evaluate the efficacy 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) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
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: E/C/F/TDF
    150/150/200/300 mg FDC tablet administered orally once daily
    Other Name: Stribild®
  • Drug: E/C/F/TAF Placebo
    Tablet administered orally once daily
  • Drug: E/C/F/TAF
    150/150/200/10 mg FDC tablet administered orally once daily
    Other Name: Genvoya®
  • Drug: E/C/F/TDF Placebo
    Tablet administered orally once daily
Study Arms  ICMJE
  • Experimental: E/C/F/TAF
    E/C/F/TAF plus E/C/F/TDF placebo for at least 48 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 at least 48 weeks
    Interventions:
    • Drug: E/C/F/TDF
    • Drug: E/C/F/TAF Placebo
  • Experimental: E/C/F/TAF Open-Label

    Following study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase.

    Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase.

    Intervention: Drug: E/C/F/TAF
Publications * Sax PE, Zolopa A, Brar I, Elion R, Ortiz R, Post F, Wang H, Callebaut C, Martin H, Fordyce MW, McCallister S. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):52-8. doi: 10.1097/QAI.0000000000000225.

*   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: June 18, 2015)
279
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2011)
150
Actual Study Completion Date  ICMJE August 22, 2016
Actual Primary Completion Date October 17, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Ability to understand and sign a written informed consent form
  • Plasma HIV 1 RNA levels ≥ 5,000 copies/mL
  • No prior use of any approved or experimental anti-HIV drug for any length of time
  • Screening genotype report must show sensitivity to TDF and emtricitabine (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 the normal range (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • CD4+ cell count > 50 cells/µL
  • Serum amylase ≤ 5 x ULN
  • 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 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
  • 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 at screening
  • 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
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Key Exclusion Criteria:

  • 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
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir and cobicistat
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
  • Current alcohol or substance
  • History of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma or resected, non-invasive cutaneous squamous carcinoma
  • 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
  • Medications contraindicated for use with emtricitabine or tenofovir disoproxil fumarate
  • Any known allergies to the excipients of E/C/F/TAF or E/C/F/TDF FDC tablets
  • Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 NCT01497899
Other Study ID Numbers  ICMJE GS-US-292-0102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date August 2017

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