Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
Status:
Completed
Trial end date:
2018-07-13
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Sofosbuvir