A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)
1 other identifier
interventional
238
1 country
37
Brief Summary
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2014
Shorter than P25 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
October 27, 2015
CompletedOctober 27, 2015
August 1, 2015
8 months
January 9, 2014
August 21, 2015
September 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA \<lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
At follow-up Week 12
Secondary Outcomes (9)
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
At follow-up Week 12
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
At follow-up Week 12
Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)
At follow-up Week 12
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24
Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
- +4 more secondary outcomes
Study Arms (3)
Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks
EXPERIMENTALTreatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks
EXPERIMENTALTreatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks
Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks
EXPERIMENTALTreatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- 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
You may not qualify if:
- Presence of AIDs-defining opportunistic infections, as defined by the Centers of Disease Control and Prevention, within 12 weeks prior to study entry
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
Va Long Beach Healthcare System
Long Beach, California, 90822, United States
Peter J Ruane Md Inc
Los Angeles, California, 90036, United States
Anthony M. Mills Md Inc
Los Angeles, California, 90069, United States
Jeffrey Goodman Special Care Clinic
Los Angeles, California, 90232, United States
Ucsd Antiviral Research Center (Avrc)
San Diego, California, 92103, United States
Precision Research Institute, Llc
San Diego, California, 92114, United States
University Of California San Francisco
San Francisco, California, 94110, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Whitman Walker Health
Washington D.C., District of Columbia, 20009, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Capital Medical Associates
Washington D.C., District of Columbia, 20036, United States
Midway Immunology And Research Center
Ft. Pierce, Florida, 34982, United States
University Of Miami Schiff Center For Liver Diseases
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Infect. Disease Specialists
Decatur, Georgia, 30033, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, 46202, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Southwest Care Center
Sante Fe, New Mexico, 87505, United States
Binghamton Gastroenterology Associates
Binghamton, New York, 13903, United States
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029, United States
University Of Cincinnati
Cincinnati, Ohio, 45267, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
Oregon Health Science Univ
Portland, Oregon, 97239, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18102, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Tarrant County Inf Dis Assoc
Fort Worth, Texas, 76104, United States
Cure C Consortium
Houston, Texas, 77004, United States
University Of Texas Health Science Center At Houston
Houston, Texas, 77030, United States
Clinical Research Centers Of America
Murray, Utah, 84123, United States
Mcguire D V A M C
Richmond, Virginia, 23249, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (2)
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.
PMID: 27025835DERIVEDWyles 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.
PMID: 26196502DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 10, 2014
Study Start
February 1, 2014
Primary Completion
October 1, 2014
Study Completion
January 1, 2015
Last Updated
October 27, 2015
Results First Posted
October 27, 2015
Record last verified: 2015-08