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Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication

NCT03823911•University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

This is an interventional, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \> or equal to 18 years old
•2. Able and willing to sign informed consent
•3. Chronically infected with any HCV genotype (1a, 1b, 2, 3, 4, 5, or 6), defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater)
•4. If HIV+, suppressed on a stable, protocol-approved, ARV regimen for ≥ 8 weeks prior to starting HCV treatment
•1. HIV RNA \< 50 copies/mL (or \< LLOQ if the local laboratory assay's LLOQ is ≥50 copies/mL) prior to Screening. Subjects with an isolated or unconfirmed HIV RNA \> 50 copies/mL (or \> LLOQ if the local laboratory assay's LLOQ is ≥50 copies/mL) are not excluded.
•2. CD4 count \>100 cells/mm3
•5. Willing to have samples stored for future use
•6. If tested positive for NS5A resistance-associated polymorphisms or PEG-IFN and ribavirin experienced, able to tolerate ribavirin-containing regimen for 16 weeks. Ribavirin will be administered at the discretion of the PI.
•7. Women of childbearing potential who receive ribavirin will have to be willing to commit to abstinence from sexual activity, or use of two forms of contraceptive during treatment and for the 6 months after completion of ribavirin. Men receiving ribavirin who are sexually active with women will also have to be willing to commit to abstinence from sexual activity, or use of two forms of contraceptive during treatment and for the 6 months after completion of ribavirin.

Exclusion Criteria

•1. Decompensated liver disease (Childs Pugh B or C)
•2. Unable to comply with research study visits
•3. Poor venous access not allowing screening laboratory collection
•4. Have any condition that the investigator considers a contraindication to study participation
•5. Pregnant or breastfeeding woman
•6. Prior HCV treatment with Direct-Acting Antivirals. Note: Patients who are treatment-experienced with PEG-IFN/RBV will not be excluded; their inclusion in the study will be considered by the PI.
•7. HIV+ patients with prior HCV treatment who achieved sustained virologic response (SVR)/ functional cure
•8. Use of a concomitant medication that is contraindicated with the use of the DAA for HCV treatment (per package insert)
•9. Coinfection with HCV and HBV, in partcular HBsAg + patients.
•a. Patients with HBcAb+ will not be excluded, but will have HBV DNA levels checked and will be monitored while on DAA therapy and medically managed as considered appropriate by the PI.
+13 more criteria

Locations (2)

Unity Parkside Health Center

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

Institute of Human Virology, CRU

Baltimore, Maryland, United States

Key Dates

Start Date

November 18, 2018

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2022

Last Updated

May 22, 2023

Enrollment

ACTUAL participants

Conditions

Cardiovascular DiseasesHepatitis CHiv

Interventions

Elbasvir / Grazoprevir Oral Tablet [Zepatier]

DRUG

Cardiac MRI

PROCEDURE

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

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Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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RECRUITING

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITINGPHASE2

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

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: May 22, 2023Data 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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Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication

Inclusion Criteria

Exclusion Criteria

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

Thinking and Memory Problems in People With HIV

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

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

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

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption