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Completed

NCT Number: NCT02823457

VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C

This study implement a values-based motivational interviewing (VBMI) intervention to promote treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30 Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C virus (HCV) infection.

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Key information

About this study

The investigators will conduct a prospective study of 30 Veterans with treatment-naive genotype 1 chronic hepatitis C infection admitted to the Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) at the G.V. (Sonny) Montgomery VA Medical Center. Enrolled veterans will be treated MK-5172/MI-8742 while receiving a 12 week values based motivational intervention to promote completion of HCV treatment. MK-5172/MK-8742 will be prescribed in accordance with the package insert.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who are genotype 1a must have baseline NS5a resistance testing
  • Current resident of the SARRTP program
  • Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days post-discharge.
  • Willing to attend coordinated HCV treatment clinic visits and substance abuse aftercare visits every 2 weeks upon SARRTP discharge

Exclusion criteria

  • Contraindications for therapy with FDC MK-5172/MK-8742
  • Unable to provide written informed consent
  • Hepatocellular carcinoma or other medical condition precluding HCV treatment
  • Acute HCV infection
  • Prior treatment for chronic HCV
  • History of decompensated cirrhosis
  • Platelet count < 75 K/cmm and/or albumin < 3 grams/dL
  • Females and male sex partners of females who are pregnant, nursing and/or unwilling to use contraception
  • Patients infected with genotype 1a who have not undergone baseline NS5a resistance testing

Treatment and study plan

VBMI

Behavioral

12 week values based motivational interviewing intervention with a licensed psychologist

Other names: Values Based Motivational Interviewing

Primary outcomes

  1. Treatment Completion

    Time frame: 12 weeks after initiation treatment

    Number of participants who completed treatment

Secondary outcomes

  1. Sustained Virologic Response

    Time frame: an average of 3 months after treatment completion

    Number of participants who achieved SVR

Sponsors and collaborators

Lead sponsor

G.V. (Sonny) Montgomery VA Medical Center

Fed

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Evaluating Values-based Motivational Interviewing to Increase Treatment Completion With Fixed Dose Combination MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders and Treatment-naïve Genotype 1 Chronic Hepatitis C

Acronym: VBMI SUD/HCV

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 6, 2016
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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