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Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01108510
First received: April 20, 2010
Last updated: October 23, 2014
Last verified: October 2014

April 20, 2010
October 23, 2014
May 2010
November 2011   (final data collection date for primary outcome measure)
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot algorithm.
The primary efficacy endpoint is the proportion of subjects that achieve HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01108510 on ClinicalTrials.gov Archive Site
Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
The change from baseline in CD4 cell count at Week 48 was analyzed.
  • The proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • The change from baseline in CD4+ cell count at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • The change from baseline in CD4+ cell count at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
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-Naïve Adults

This study is designed to evaluate the safety and efficacy of a regimen containing Cobicistat (COBI)-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1-infected, antiretroviral treatment-naive adults. Development of COBI as a "pharmacoenhancer" could provide a beneficial alternative to RTV for use in combination with protease inhibitors.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Drug: Cobicistat
    Cobicistat (COBI) 150 mg tablet administered orally once daily
    Other Names:
    • Tybost®
    • GS-9350
  • Drug: Ritonavir
    Ritonavir (RTV) 100 mg tablet administered orally once daily
    Other Name: Norvir®
  • Drug: Atazanavir
    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: Placebo to match COBI
    Placebo to match COBI administered orally once daily
  • Drug: Placebo to match RTV
    Placebo to match RTV administered orally once daily
  • Experimental: ATV/co+FTC/TDF
    Participants will be randomized to receive COBI 150 mg, plus placebo to match RTV, plus ATV 300 mg, plus FTC 200 mg/TDF 300 mg once daily.
    Interventions:
    • Drug: Cobicistat
    • Drug: Atazanavir
    • Drug: FTC/TDF
    • Drug: Placebo to match RTV
  • Active Comparator: ATV/r+FTC/TDF
    Participants will be randomized to receive RTV 100 mg, plus placebo to match COBI, plus ATV 300 mg, plus FTC 200 mg/TDF 300 mg once daily.
    Interventions:
    • Drug: Ritonavir
    • Drug: Atazanavir
    • Drug: FTC/TDF
    • Drug: Placebo to match COBI
Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJesus E, Antunes F, Arastéh K, Moyle G, Rizzardini G, Fehr J, Liu Y, Zhong L, Callebaut C, Szwarcberg J, Rhee MS, Cheng AK. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013 Jul;208(1):32-9. doi: 10.1093/infdis/jit122. Epub 2013 Mar 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
698
January 2015
November 2011   (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 ≥ 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 day s 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.
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,   Switzerland,   Thailand,   United Kingdom
 
NCT01108510
GS-US-216-0114
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Huyen Cao, MD Gilead Sciences
Gilead Sciences
October 2014

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