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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01815736
First received: March 19, 2013
Last updated: November 11, 2014
Last verified: November 2014

March 19, 2013
November 11, 2014
March 2013
March 2015   (final data collection date for primary outcome measure)
The proportion of participants who have HIV-1 RNA < 50 copies/mL at Week 48 [ 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 NCT01815736 on ClinicalTrials.gov Archive Site
  • Percent change from baseline in hip bone mineral density [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in spine bone mineral density [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in serum creatinine [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in efavirenz-related symptom assessment score [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • To determine the safety by the percent change from baseline in hip and spine 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 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 ] [ 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
 
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
A Phase 3, Open-Label Study to Evaluate Switching From a TDF-containing Combination Regimens to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-suppressed, HIV-1 Positive Subjects

This randomized, open-label, active-controlled study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-Containing Combination single tablet regimen (STR) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically-suppressed HIV-1 positive subjects as determined by having HIV-1 RNA < 50 copies/mL at Week 48 following the switch.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Drug: E/C/F/TAF
    Single-tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) administered orally once daily
  • Drug: E/C/F/TDF
    Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) tablets administered orally once daily
    Other Name: Stribild® (E/C/F/TDF)
  • Drug: EFV/FTC/TDF
    Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF) tablets administered orally once daily
    Other Name: Atripla® (EFV/FTC/TDF)
  • Drug: RTV
    Ritonavir (RTV) 100 mg tablets administered orally once daily
  • Drug: ATV
    Atazanavir (ATV) 300 mg capsules administered orally once daily
  • Drug: FTC/TDF
    Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) tablets administered orally once daily
    Other Name: Truvada® (FTC/TDF)
  • Drug: COBI
    Cobicistat (COBI) 150 mg tablets administered orally once daily
    Other Names:
    • Tybost®
    • GS-9350
  • Experimental: E/C/F/TAF switch
    Participants will switch to STR of E/C/F/TAF for 48 weeks.
    Intervention: Drug: E/C/F/TAF
  • Active Comparator: Maintain pre-existing regimen
    Participants will maintain their pre-existing regimen of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for 48 weeks.
    Interventions:
    • Drug: E/C/F/TDF
    • Drug: EFV/FTC/TDF
    • Drug: RTV
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: COBI
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
1500
February 2016
March 2015   (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
  • Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, ATV/r + FTC/TDF, or ATV/co + 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 subjects on an efavirenz-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 mg/dL
  • 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 30 days following the last dose of study drug
  • 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 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 position
  • Hepatitis C antibody positive
  • Subjects 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
  • Subjects receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), cobicistat (COBI), FTC, TDF, ATV, ritonavir (RTV), EFV, and TAF or subjects with any known allergies to the excipients of E/C/F/TDF STR, E/C/F/TAF STR, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   Dominican Republic,   France,   Germany,   Italy,   Mexico,   Netherlands,   Portugal,   Puerto Rico,   Spain,   Sweden,   Switzerland,   Thailand,   United Kingdom
 
NCT01815736
GS-US-292-0109, 2012-005114-20
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Scott McCallister, MD Gilead Sciences
Gilead Sciences
November 2014

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