A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Sites / Locations
- University Of Alabama At Birmingham
- Pacific Oaks Medical Group
- Va Long Beach Healthcare System
- Peter J Ruane Md Inc
- Anthony M. Mills Md Inc
- Jeffrey Goodman Special Care Clinic
- Ucsd Antiviral Research Center (Avrc)
- Precision Research Institute, Llc
- University Of California San Francisco
- University Of Colorado
- Whitman Walker Health
- Medstar Washington Hospital Center
- Capital Medical Associates
- Midway Immunology And Research Center
- University Of Miami Schiff Center For Liver Diseases
- Orlando Immunology Center
- Infect. Disease Specialists
- Indiana University Health - University Hospital
- Digestive Disease Associates, P.A.
- Johns Hopkins University
- Henry Ford Health System
- Washington University School Of Medicine
- Southwest Care Center
- Binghamton Gastroenterology Associates
- Icahn School Of Medicine At Mount Sinai
- University Of Cincinnati
- Healthcare Research Consultants
- Oregon Health Science Univ
- Lehigh Valley Health Network
- University Gastroenterology
- The Miriam Hospital
- Tarrant County Inf Dis Assoc
- Cure C Consortium
- University Of Texas Health Science Center At Houston
- Clinical Research Centers Of America
- Mcguire D V A M C
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks
Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks
Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks
Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks
Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks