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Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

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ClinicalTrials.gov Identifier: NCT01815736
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Results First Posted : April 14, 2016
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 19, 2013
First Posted Date  ICMJE March 21, 2013
Results First Submitted Date  ICMJE March 15, 2016
Results First Posted Date  ICMJE April 14, 2016
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE March 27, 2013
Actual Primary Completion Date March 16, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
The proportion of subjects who have HIV-1 RNA < 50 copies/mL [ Time Frame: 48 Weeks ]
The primary efficacy endpoint is determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48
Change History Complete list of historical versions of study NCT01815736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline; Week 48 ]
    Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.
  • Percent Change From Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
    Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.
  • Change From Baseline in Serum Creatinine at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48 [ Time Frame: Baseline; Week 48 ]
    The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
  • To determine the safety by the percent change from baseline in hip and spine bone mineral density [ Time Frame: 48 Weeks ]
    To determine the safety of the two treatment regimens as determined by the percent change from baseline in hip and spine bone mineral density at Week 48
  • To determine the safety determined by the change from baseline in serum creatinine at Week 48 [ Time Frame: Week 48 ]
    To determine the safety of the two treatment regimens as determined by the change from baseline in serum creatinine at Week 48
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Official Title  ICMJE A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Brief Summary This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • HIV Infections
Intervention  ICMJE
  • Drug: E/C/F/TAF
    Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered orally once daily
    Other Name: Genvoya®
  • Drug: E/C/F/TDF
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (150/150/200/300 mg) FDC tablet administered orally once daily
    Other Name: Stribild®
  • Drug: EFV/FTC/TDF
    Efavirenz (EFV)/FTC/TDF (600/200/300 mg) FDC tablet administered orally once daily
    Other Name: Atripla®
  • Drug: RTV
    Ritonavir (RTV) 100 mg tablet administered orally once daily
    Other Name: Norvir®
  • Drug: ATV
    Atazanavir (ATV) 300 mg capsule administered orally once daily
    Other Name: Reyataz®
  • Drug: FTC/TDF
    Emtricitabine (FTC)/TDF (200/300 mg) tablet administered orally once daily
    Other Name: Truvada®
  • Drug: COBI
    Cobicistat (COBI) 150 mg tablet administered orally once daily
    Other Names:
    • Tybost®
    • GS-9350
Study Arms  ICMJE
  • Experimental: E/C/F/TAF
    Participants will switch to E/C/F/TAF FDC tablet for up to 96 weeks in the Randomized Phase, and may continue treatment with E/C/F/TAF in the open-label Extension Phase.
    Intervention: Drug: E/C/F/TAF
  • Active Comparator: Stay on Baseline Treatment Regimen (SBR)
    Participants will stay on their baseline FTC/tenofovir disoproxil fumarate (TDF)-containing regimen (either E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF) for up to 96 weeks in the Randomized Phase, and may switch to E/C/F/TAF in the open-label Extension Phase.
    Interventions:
    • Drug: E/C/F/TDF
    • Drug: EFV/FTC/TDF
    • Drug: RTV
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: COBI
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
1443
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2013)
1500
Estimated Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 16, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final visit in their earlier study
  • Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only participants on an EFV-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105
  • Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA < 50 copies/mL at the screening visit
  • Normal echocardiograph (ECG)
  • Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of the normal range (ULN)
  • Direct bilirubin ≤ 1.5 x ULN
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • 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 12 weeks following the last dose of study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens.
  • Female participants 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 participants 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

Key Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen position
  • Hepatitis C antibody positive
  • Participants 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 subject 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 subject unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
  • Participants receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

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 Australia,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   Dominican Republic,   France,   Germany,   Italy,   Mexico,   Netherlands,   Portugal,   Puerto Rico,   Spain,   Sweden,   Switzerland,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01815736
Other Study ID Numbers  ICMJE GS-US-292-0109
2012-005114-20 ( EudraCT Number )
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 Not Provided
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 February 2019

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