A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
NCT ID: NCT02032888
Last Updated: 2015-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
238 participants
INTERVENTIONAL
2014-02-28
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks
Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
Daclatasvir
Sofosbuvir
Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks
Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks
Daclatasvir
Sofosbuvir
Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks
Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
Daclatasvir
Sofosbuvir
Interventions
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Daclatasvir
Sofosbuvir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6, as documented by positive HCV RNA at screening
* Patients who are HCV treatment-naive
* Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies discontinued or completed at least 12 weeks prior to screening
* Patients with HCV RNA ≥10,000 IU/mL at screening
* Patients with HIV-1 infection
Exclusion Criteria
* Patients infected with HIV-2
* Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
* Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed
* Evidence of decompensated liver disease, including radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Va Long Beach Healthcare System
Long Beach, California, United States
Peter J Ruane Md Inc
Los Angeles, California, United States
Anthony M. Mills Md Inc
Los Angeles, California, United States
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States
Ucsd Antiviral Research Center (Avrc)
San Diego, California, United States
Precision Research Institute, Llc
San Diego, California, United States
University Of California San Francisco
San Francisco, California, United States
University Of Colorado
Aurora, Colorado, United States
Whitman Walker Health
Washington D.C., District of Columbia, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Capital Medical Associates
Washington D.C., District of Columbia, United States
Midway Immunology And Research Center
Ft. Pierce, Florida, United States
University Of Miami Schiff Center For Liver Diseases
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Infect. Disease Specialists
Decatur, Georgia, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States
Johns Hopkins University
Lutherville, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Southwest Care Center
Sante Fe, New Mexico, United States
Binghamton Gastroenterology Associates
Binghamton, New York, United States
Icahn School Of Medicine At Mount Sinai
New York, New York, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Oregon Health Science Univ
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Tarrant County Inf Dis Assoc
Fort Worth, Texas, United States
Cure C Consortium
Houston, Texas, United States
University Of Texas Health Science Center At Houston
Houston, Texas, United States
Clinical Research Centers Of America
Murray, Utah, United States
Mcguire D V A M C
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clin Infect Dis. 2016 Jun 15;62(12):1489-96. doi: 10.1093/cid/ciw163. Epub 2016 Mar 29.
Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI444-216
Identifier Type: -
Identifier Source: org_study_id
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