Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
NCT ID: NCT00892437
Last Updated: 2016-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2009-05-31
2015-01-31
Brief Summary
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Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ATV+COBI+FTC/TDF
COBI + RTV placebo +ATV+FTC/TDF for 48 weeks
COBI
Cobicistat (COBI) 150 mg tablet administered orally once daily
ATV
Atazanavir (ATV) 300 mg capsule administered orally once daily
FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
RTV placebo
Placebo to match RTV administered orally once daily
ATV+RTV+FTC/TDF
RTV + COBI placebo +ATV+FTC/TDF for 48 weeks
RTV
Ritonavir (RTV) 100 mg soft gelatin capsule administered orally once daily
ATV
Atazanavir (ATV) 300 mg capsule administered orally once daily
FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
COBI placebo
Placebo to match COBI administered orally once daily
Interventions
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COBI
Cobicistat (COBI) 150 mg tablet administered orally once daily
RTV
Ritonavir (RTV) 100 mg soft gelatin capsule administered orally once daily
ATV
Atazanavir (ATV) 300 mg capsule administered orally once daily
FTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
COBI placebo
Placebo to match COBI administered orally once daily
RTV placebo
Placebo to match RTV administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
* No prior use of any approved or experimental anti-HIV drug
* Normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
* Adequate renal function (estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula)
* Hepatic transaminases ≤ 2.5 × upper limit of normal
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function (absolute neutrophil count ≥ 1000/mm\^3; platelets ≥ 50,000/mm\^3; hemoglobin ≥ 8.5 g/dL)
* Cluster of differentiation 4 (CD4) cell count \> 50 cells/µL
* Serum amylase ≤ 1.5 × ULN (subjects with serum amylase \>1.5 × ULN remained eligible if serum lipase is ≤ 1.5 × ULN)
* Normal thyroid-stimulating hormone
* Negative serum pregnancy test (females of childbearing potential only)
* 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 drugs
* Age ≥ 18 years
* Life expectancy ≥ 1 year
Exclusion Criteria
* Documented drug resistance to nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or primary PI resistance mutation(s)
* Hepatitis B surface antigen positive
* Hepatitis C antibody positive
* Participants experiencing cirrhosis
* Participants experiencing ascites
* Participants experiencing encephalopathy
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Vaccinated within 90 days of study dosing
* History or family history of Long QT Syndrome or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30 years
* Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
* Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) interval at screening (eg, a prolongation of the QTcF interval of greater than 450 msec for males and greater than 470 msec for females)
* PR interval greater than or equal to 200 msec or less than or equal to 120 msec on ECG at screening
* QRS greater than or equal to 120 msec on ECG at screening
* Implanted defibrillator or pacemaker
* Subjects receiving ongoing therapy with any disallowed medications
* Current alcohol or substance use judged to potentially interfere with subject study compliance
* History of or ongoing malignancy (including untreated carcinoma in-situ) 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
* Participation in any other clinical trial without prior approval
* Medications contraindicated for use with ATV, RTV, FTC, or TDF
* Any known allergies to the excipients of ATV capsules, RTV capsules, COBI tablets or FTC/TDF tablets
* Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Marshall Fordyce, MD
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Southwest Center for HIV/AIDS
Phoenix, Arizona, United States
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States
AIDS Healthcare Foundation-Research Center
Beverly Hills, California, United States
The Living Hope Foundation
Long Beach, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
David J. Shamblaw, MD Inc.
San Diego, California, United States
Metropolis Medical
San Francisco, California, United States
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Capital Medical Associates PC
Washington D.C., District of Columbia, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, United States
ValuehealthMD, LLC
Orlando, Florida, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta (IDSA)
Decatur, Georgia, United States
Northstar Medical Center
Chicago, Illinois, United States
Chase Brexton Health Services, Inc.
Baltimore, Maryland, United States
Be Well Medical Center
Berkley, Michigan, United States
Central West Healthcare
St Louis, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, United States
Nicholaos Bellos, MD, PA
Dallas, Texas, United States
AIDS Arms/ Peabody Health Center
Dallas, Texas, United States
Gordon E. Crofoot, MD, PA
Houston, Texas, United States
Therapeutic Concepts, P.A.
Houston, Texas, United States
TribalMed
Seattle, Washington, United States
Countries
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References
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Elion R, Cohen C, Gathe J, Shalit P, Hawkins T, Liu HC, Mathias AA, Chuck SL, Kearney BP, Warren DR; GS-US-216-0105 Study Team. Phase 2 study of cobicistat versus ritonavir each with once-daily atazanavir and fixed-dose emtricitabine/tenofovir df in the initial treatment of HIV infection. AIDS. 2011 Sep 24;25(15):1881-6. doi: 10.1097/QAD.0b013e32834b4d48.
Other Identifiers
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GS-US-216-0105
Identifier Type: -
Identifier Source: org_study_id
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