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Phase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF) (ALLY 2) [treatment-naive & treatment-experienced
This study is currently recruiting participants. Verified March 2014 by Bristol-Myers Squibb
Inclusion Criteria:
· Subjects 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
· Subjects chronically infected with HCV genotype 1, 2, 3, 4, 5 or 6, as documented by positive HCV RNA at screening
· HCV-Treatment-naive subjects
· HCV treatment-experienced subjects are eligible. All permitted prior anti-HCV therapies must be discontinued or completed at least 12 weeks prior to screening
· Subjects must have an HCV RNA ≥ 10,000 IU/mL at Screening
· Subjects must have HIV-1 infection Exclusion Criteria:
· Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC)
· Subjects 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 (HCC), 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, but not limited to, radiologic criteria,a history or presence of ascites, bleeding varices, or hepatic encephalopathy
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