Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
Completed · Phase 4
Conditions studied: HCV HIV
In brief
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.
Key facts
- Study ID
- NCT02339038
- Run by
- National Institutes of Health Clinical Center (CC)
- People needed
- 600
- Starts
- 2015-01-07
- Expected to finish
- 2018-07-13
- Last updated by the study team
- 2018-08-14
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Women who are pregnant or breastfeeding
- Screening laboratory analyses showing any of the following abnormal laboratory results:
- Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min as estimated by the Modification of Diet in Renal Disease (MDRD) equation (utilized by LabCorp):
- eGFR = 175 times SerumCr(-1.154) age(-0.203 1.212 (if patient is black) 0.742 (if female)
- Diagnosis of hepatocellular carcinoma as defined by pre-screening medical history
- Any other conditions in the opinion of the investigator that would interfere with the compliance or endpoints of the study.
Where it is running
- Unity Health Care, Inc./DC General — Washington D.C., District of Columbia, United States
- Family Medical and Conseling Services — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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