Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
NCT ID: NCT01363011
Last Updated: 2016-05-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2011-05-31
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
NCT01440569
Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults
NCT02246998
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
NCT01565850
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
NCT01818596
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
NCT06337032
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
E/C/F/TDF (Cohort 1)
Participants who have not received prior antiretroviral (ARV) treatment and who are virologically unsuppressed at baseline will initiate treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) single-tablet regimen (STR) for up to 96 weeks.
Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country.
E/C/F/TDF
E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily
COBI+PI+2 NRTI (Cohort 2)
Participants who have received prior ARV treatment and who are virologically suppressed at baseline will continue their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to cobicistat (COBI), and continuing their existing protease inhibitor (PI; either atazanavir (ATV) or darunavir (DRV)) plus 2 nucleoside reverse transcriptase inhibitor (NRTI) regimen for up to 96 weeks.
Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.
COBI
COBI 150 mg tablet administered with food orally once daily
ATV
ATV 300 mg tablet administered orally once daily
DRV
DRV 800 mg tablet administered orally once daily
NRTI
Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E/C/F/TDF
E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily
COBI
COBI 150 mg tablet administered with food orally once daily
ATV
ATV 300 mg tablet administered orally once daily
DRV
DRV 800 mg tablet administered orally once daily
NRTI
Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
* Screening genotype report must show sensitivity to FTC and TDF
* No prior use of any approved or investigational antiretroviral drug for any length of time
Cohort 2 (treatment-experienced, pharmacoenhancer switch)
* Subjects must be receiving ATV 300 mg/ritonavir (RTV) 100 mg plus 2 NRTIs OR DRV 800 mg/RTV 100 mg plus 2 NRTIs for at least 6 months prior to screening
* Plasma HIV-1 RNA concentrations at undetectable levels in the 6 months preceding the screening visit and have HIV-1 RNA \< 50 copies/mL at screening
* Subjects experiencing intolerance to RTV (as determined by the investigator)
Both groups
* The ability to understand and sign a written informed consent form
* Normal ECG
* Mild to moderate renal function
* Stable renal function
* Hepatic transaminases (AST and ALT) ≤ 5 x the upper limit of the normal range (ULN)
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (subjects with documented Gilbert's Syndrome or hyperbilirubinemia due to atazanavir therapy may have total bilirubin up to 5 x ULN)
* 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
Exclusion Criteria
* 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)
* 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
* Receiving ongoing therapy with any of medications contraindicated for use with elvitegravir (EVG), COBI, FTC, TDF, ATV, DRV; or subjects with any known allergies to the excipients of E/C/F/TDF STR, COBI tablets, ATV capsules or DRV tablets or contraindicated for the 2 NRTIs as part of the PI/co regimen
* Participation in any other clinical trial without prior approval
* 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Javier Szwarcberg, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spectrum Medical Group
Phoenix, Arizona, United States
Health for Life Clinic
Little Rock, Arkansas, United States
AHF Research Center
Beverly Hills, California, United States
Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, M.D., Inc.
Los Angeles, California, United States
Anthony Mills, MD, Inc.
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
East Bay AIDS Center
Oakland, California, United States
University of California, Davis
Sacramento, California, United States
Metropolis Medical
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine AIDS Program
New Haven, Connecticut, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Medical Faculty Associates
Washington D.C., District of Columbia, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Broward Health
Fort Lauderdale, Florida, United States
Gary J. Richmond.M.D.,P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
IDOCF/ValueHealthMD, LLC
Orlando, Florida, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University/ Mercer Medicine Clinical Research
Macon, Georgia, United States
Northstar Medical Center
Chicago, Illinois, United States
The Research Institute
Springfield, Massachusetts, United States
Central West Clinical Research, Inc.
St Louis, Missouri, United States
ID Care
Hillsborough, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Chelsea Village Medical
New York, New York, United States
Mount Sinai Downtown Comprehensive Health Program
New York, New York, United States
AIDS Care
Rochester, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Southwest Infectious Disease Clinical Research, Inc.
Addison, Texas, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Taylor Square Private Clinic
Darlinghurst, , Australia
Infectious Diseases Unit - The Alfred Hospital
Melbourne, , Australia
Holdsworth House Medical Practice
Sydney, , Australia
Landeskrankenhaus Graz West
Graz, , Austria
Otto Wagner Spital
Vienna, , Austria
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
Montreal, , Canada
Instituto Dominicano de Estudio Virologicos
Santo Domingo, , Dominican Republic
Center for HIV and Hepatogastroenterology
Düsseldorf, , Germany
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, , Mexico
Clinical Research Puerto Rico
San Juan, , Puerto Rico
HOPE Clinical Research
San Juan, , Puerto Rico
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Barts & the London NHS Trust
London, , United Kingdom
Homerton University Hospital
London, , United Kingdom
Guy's King's and St. Thomas' School of Medicine
London, , United Kingdom
St Stephen's AIDS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fisher M, McDonald C, Moyle G, Martorell C, Ramgopal M, Laplante F, Curley J, Graham H, Tran-Muchowski C, Liu Y, Rhee M, Szwarcberg J. Switching from ritonavir to cobicistat in HIV patients with renal impairment who are virologically suppressed on a protease inhibitor. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19824. doi: 10.7448/IAS.17.4.19824. eCollection 2014.
Post FA, Winston J, Andrade-Villanueva JF, Fisher M, Liu Y, Beraud C, Abram ME, Graham H, Rhee MS, Cheng AK, Szwarcberg J; Study 118 Team. Elvitegravir/cobicistat/emtricitabine/tenofovir DF in HIV-infected patients with mild-to-moderate renal impairment. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):310-3. doi: 10.1097/QAI.0000000000000476.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GS-US-236-0118
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.