At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 68 enrolled
Drug / intervention
Harvonidrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Retrospective/Prospective Cohort Study to Assess Safety, Tolerability, and Efficacy of Sofosbuvir Based Direct Acting Antiviral (DAA) Therapy for Hepatitis C Treatment in HIV/HCV Coinfected Subjects Pre or Post Liver Transplant
In Brief
A Phase 4 clinical trial evaluating Harvoni for HIV and 2 related conditions. Completed, enrolled 68 participants across 8 sites.
Detailed Summary
Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Hepatitis C, Cirrhosis
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Icahn School of Medicine at Mount Sinai, Columbia University, University of Pennsylvania, University of Maryland, College Park, Georgetown University, Johns Hopkins University, National Institutes of Health Clinical Center (CC)
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartAug 2016
Primary CompletionDec 2019
TodayJul 2026
First PostedAug 27, 2015
Enrollment StartAug 1, 2016
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.8 years ago
Interventions
Harvonidrug
Treatment of Hepatitis C with sofosbuvir based HCC therapy