CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 600 enrolled
Drug / intervention
Ledipasvir 90 mg and Sofosbuvir 400 mgdrug
Likely dose
Ledipasvir 90 mg and Sofosbuvir 400 mgfrom 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.

Search/NCT02339038
NCT02339038Phase 4Completed

A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

National Institutes of Health Clinical Center (CC)·interventional·Posted Jan 15, 2015·Updated Aug 14, 2018

In Brief

A Phase 4 clinical trial evaluating Ledipasvir 90 mg and Sofosbuvir 400 mg for HCV HIV. Completed, enrolled 600 participants across 2 sites.

Detailed Summary

Background: \- Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia. Objectives: \- To see if people can be treated for Hepatitis C safely and successfully in community-based health centers. Eligibility: \- Adults who need treatment for chronic Hepatitis C infection. Design: * Participants will be screened with blood tests. Their current medicines will be reviewed. * Participants will give researchers access to their medical records. Researchers will follow participants through these records. * Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits. * Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly. * Participants will have monthly follow-up visits for up to 3 months after they finish their medicine. * Participants will have yearly follow-up visits with their care provider for up to 10 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHCV HIV
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 15, 2015
Enrollment StartJan 7, 2015
Primary CompletionJun 15, 2016
Study CompletionJul 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.5 years ago

Interventions

Ledipasvir 90 mg and Sofosbuvir 400 mgdrug

Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination as per standard of care treatment guidelines