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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01108510




Registration number
NCT01108510
Ethics application status
Date submitted
20/04/2010
Date registered
22/04/2010
Date last updated
23/05/2016

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2009-016759-22
Secondary ID [2] 0 0
GS-US-216-0114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - COBI
Treatment: Drugs - RTV
Treatment: Drugs - ATV
Treatment: Drugs - FTC/TDF
Treatment: Drugs - COBI placebo
Treatment: Drugs - RTV placebo

Experimental: ATV+COBI+FTC/TDF - COBI + RTV placebo + ATV + FTC/TDF once daily

Active comparator: ATV+RTV+FTC/TDF - RTV + COBI placebo + ATV + FTC/TDF once daily


Treatment: Drugs: COBI
Cobicistat (COBI) 150 mg tablet administered orally once daily

Treatment: Drugs: RTV
Ritonavir (RTV) 100 mg tablet administered orally once daily

Treatment: Drugs: ATV
Atazanavir (ATV) 300 mg capsule administered orally once daily

Treatment: Drugs: FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily

Treatment: Drugs: COBI placebo
Placebo to match COBI administered orally once daily

Treatment: Drugs: RTV placebo
Placebo to match RTV administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Timepoint [1] 0 0
Week 96
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
Timepoint [2] 0 0
Week 144
Secondary outcome [3] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
Timepoint [3] 0 0
Week 192
Secondary outcome [4] 0 0
Change From Baseline in CD4 Cell Count at Week 48
Timepoint [4] 0 0
Baseline to Week 48
Secondary outcome [5] 0 0
Change From Baseline in CD4 Cell Count at Week 96
Timepoint [5] 0 0
Baseline to Week 96
Secondary outcome [6] 0 0
Change From Baseline in CD4 Cell Count at Week 144
Timepoint [6] 0 0
Baseline to Week 144
Secondary outcome [7] 0 0
Change From Baseline in CD4 Cell Count at Week 192
Timepoint [7] 0 0
Baseline to Week 192

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
698
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [3] 0 0
Albion Street Centre - Sydney
Recruitment hospital [4] 0 0
Holdsworth House Medical practice - Sydney
Recruitment hospital [5] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [6] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Northside Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3068 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
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United States of America
State/province [4] 0 0
California
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United States of America
State/province [5] 0 0
Colorado
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United States of America
State/province [6] 0 0
District of Columbia
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United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
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Illinois
Country [10] 0 0
United States of America
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Maryland
Country [11] 0 0
United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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Missouri
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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North Carolina
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Pennsylvania
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South Carolina
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United States of America
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Austria
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Graz
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Ghent
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Brazil
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RJ
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Brazil
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Sao Paulo
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Brazil
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Campinas
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Brazil
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São Paulo
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Montreal
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Denmark
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Copenhagen
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Dominican Republic
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Santo Domingo
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France
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Caen
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France
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Lyon
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France
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Marseille
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France
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Nantes
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France
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Paris
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France
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Pessac
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France
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Tourcoing
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Germany
State/province [49] 0 0
Koln
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Italy
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Milano
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Italy
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Milan
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Italy
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Roma
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Italy
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Torino
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Mexico
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Jalisco
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Netherlands
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Amsterdam
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Portugal
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Lisbon
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Portugal
State/province [57] 0 0
Porto
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Spain
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Madrid
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Spain
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Sevilla
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Switzerland
State/province [62] 0 0
VD
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Switzerland
State/province [63] 0 0
Bern
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Switzerland
State/province [64] 0 0
Zürich
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Thailand
State/province [65] 0 0
Bangkok
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Thailand
State/province [66] 0 0
Chiang Mai
Country [67] 0 0
Thailand
State/province [67] 0 0
Khon Kaen
Country [68] 0 0
United Kingdom
State/province [68] 0 0
East Sussex
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01108510
Trial related presentations / publications
Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJesus E, Antunes F, Arasteh 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.
Gallant JE, Koenig E, Andrade-Villanueva JF, Chetchotisakd P, DeJesus E, Antunes F, Arasteh K, Rizzardini G, Fehr J, Liu HC, Abram ME, Cao H, Szwarcberg J. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):338-40. doi: 10.1097/QAI.0000000000000598.
Gallant J, Moyle G, Berenguer J, Shalit P, Cao H, Liu YP, Myers J, Rosenblatt L, Yang L, Szwarcberg J. Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial. Curr HIV Res. 2017;15(3):216-224. doi: 10.2174/1570162X14666161021102728.
Public notes

Contacts
Principal investigator
Name 0 0
Huyen Cao, MD
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01108510