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Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01108510
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 28, 2014
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE April 20, 2010
First Posted Date  ICMJE April 22, 2010
Results First Submitted Date  ICMJE October 23, 2014
Results First Posted Date  ICMJE October 28, 2014
Last Update Posted Date May 23, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
The primary efficacy endpoint is the proportion of subjects that achieve HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ]
Change History Complete list of historical versions of study NCT01108510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 [ Time Frame: Week 96 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 [ Time Frame: Week 144 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 [ Time Frame: Week 192 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
  • Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ]
  • Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline to Week 96 ]
  • Change From Baseline in CD4 Cell Count at Week 144 [ Time Frame: Baseline to Week 144 ]
  • Change From Baseline in CD4 Cell Count at Week 192 [ Time Frame: Baseline to Week 192 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
  • The proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 96 [ Time Frame: 96 Weeks ]
  • The change from baseline in CD4+ cell count at Week 48 [ Time Frame: 48 Weeks ]
  • The change from baseline in CD4+ cell count at Week 96 [ Time Frame: 96 Weeks ]
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 COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Brief Summary

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • HIV Infections
Intervention  ICMJE
  • Drug: COBI
    Cobicistat (COBI) 150 mg tablet administered orally once daily
    Other Names:
    • Tybost®
    • GS-9350
  • 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) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
    Other Name: Truvada®
  • Drug: COBI placebo
    Placebo to match COBI administered orally once daily
  • Drug: RTV placebo
    Placebo to match RTV administered orally once daily
Study Arms  ICMJE
  • Experimental: ATV+COBI+FTC/TDF
    COBI + RTV placebo + ATV + FTC/TDF once daily
    Interventions:
    • Drug: COBI
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: RTV placebo
  • Active Comparator: ATV+RTV+FTC/TDF
    RTV + COBI placebo + ATV + FTC/TDF once daily
    Interventions:
    • Drug: RTV
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: COBI placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
698
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2010)
700
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥ 5,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time
  • Screening genotype report must show sensitivity to FTC, TDF and ATV
  • Normal ECG
  • Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Males and 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 drug.
  • Age ≥ 18 years
  • Life expectancy ≥ 1 year

Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
  • Subjects experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test (female of childbearing potential)
  • Have an implanted defibrillator or pacemaker
  • Have an ECG PR interval ≥ 220 msec
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
  • A history of malignancy within the past 5 years or ongoing malignancy 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.
  • Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
  • Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
  • 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 the dosing requirements.
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,   Switzerland,   Thailand,   United Kingdom,   United States
Removed Location Countries Argentina,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT01108510
Other Study ID Numbers  ICMJE GS-US-216-0114
2009-016759-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Huyen Cao, MD Gilead Sciences
PRS Account Gilead Sciences
Verification Date April 2016

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