Directly Observed Therapy for HCV in Chennai, India
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24
weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited
setting. The investigators will compare treatment completion rates among 50 persons
chronically infected with HCV who will be randomized to receive either 1) 12 weeks of
sofosbuvir (SOF) + ribavirin (RBV) + pegylated interferon alfa-2a (PEG); or 2) 24 weeks of
SOF + RBV. Treatment will be delivered daily by field workers at a location of a participants
choosing. Secondary objectives are 1) To compare the efficacy of SOF+RBV with or without PEG
as measured by the proportion of subjects with sustained viral response at 12 weeks after
discontinuation of therapy (SVR12); 2) To evaluate the safety and tolerability of SOF+RBV
with or without PEG; 3) To assess the impact of SVR12 on insulin resistance.
Phase:
Phase 2
Details
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
National Institute on Drug Abuse (NIDA) YR Gaitonde Centre for AIDS Research and Education