Overview

A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Sofosbuvir
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