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Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

NCT02339038 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-08-14

Study results available
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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.

Conditions

  • HCV HIV

Interventions

DRUG

Ledipasvir 90 mg and Sofosbuvir 400 mg

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

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Henry Masur, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-07
Primary Completion
2016-06-15
Completion
2018-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339038 on ClinicalTrials.gov