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Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant

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

NCT02533934•University of California, San Francisco

View on ClinicalTrials.gov

Summary

Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants

Detailed Description

Approximately fifty HIV/HCV coinfected patients with decompensated liver disease will be enrolled in the study. Ten (up to twenty) subjects will be treated with FDC SOF/LDV pre or post liver transplant and followed prospectively. Forty + subjects will be enrolled retrospectively with the intent to capture all patients who have been exposed to sofosbuvir based DAA therapies at participating sites since 1/2014, and to mirror the population being enrolled prospectively. In addition, participants in the retrospective arm will be contacted to consent to one prospective study visit for liver staging to determine rates of reversal of decompensation, reversal of cirrhosis and improvements in graft survival post treatment, and for future contact by the NIH Clinical Center to assess longer term outcomes when this study ends.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The intent of the Retrospective Arm is to capture all HIV/HCV coinfected patients exposed to sofosbuvir based DAA therapy since 2014, to mirror the population enrolled in the Prospective Arm.
•Liver transplant candidates (listed) and decompensated cirrhotics (not listed) for liver transplant
•1. Treated with sofosbuvir based DAA for any duration since 2014
•2. Age \>18 years at time of treatment
•3. Pre-treatment Child's Pugh score of 7 or greater
•4. Pre-treatment laboratory MELD \>=6 and \<=0
•5. Survived at least 12 weeks after start of treatment
•6. HIV-positive on stable ART for at least 4 weeks pre-treatment
•7. Chronic HCV infection with at least one measurement of plasma HCV RNA \>= 1,000 IU/mL prior to treatment with sofosbuvir based DAA therapy
•8. HCV genotype 1, 4, 5 or 6
+35 more criteria

Exclusion Criteria

•Pre-liver transplant candidates
•Enrollment will be targeted to occur at least 12 weeks prior to anticipated transplant date.
•Screening laboratory MELD \>=6 and \<=20 (NIH) or \<=30 (non-NIH sites)
•Post-liver transplant recipients
•Recipients with evidence of recurrent HCV viremia
•Subjects with compensated and decompensated liver disease
•Screening laboratory MELD \>=6 and \<=20 (NIH) or \<=30 (non-NIH sites)
•Life expectation of \>12 weeks
•1. Positive HBsAg at screening.
•2. History of any other clinically active chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson's disease, \>=1 antitrypsin deficiency, alcoholic liver disease, and toxin exposures).
+19 more criteria

Locations (8)

University of California, San Francisco

San Francisco, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins Medical Center

Baltimore, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Mt. Sinai Medical Center

New York, New York, United States

Columbia University

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

December 31, 2019

Completion Date

December 31, 2019

Last Updated

February 2, 2021

Enrollment

ACTUAL participants

Conditions

HIVHepatitis CCirrhosis

Interventions

Harvoni

DRUG

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

NCT05597488

Cirrhosis Portal

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RECRUITING

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant

Inclusion Criteria

Exclusion Criteria

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Thinking and Memory Problems in People With HIV

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

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