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Antiviral Pharmacology and Adherence in Drug Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02573376
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : January 22, 2020
Denver Health and Hospital Authority
National Institute on Drug Abuse (NIDA)
Gilead Sciences
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. This assumption can only be confirmed or dispelled through prospective pharmacologic and adherence studies in this population. Such studies would be greatly enhanced by an objective, quantitative measure of adherence which does not currently exist in the HCV field. Through the work proposed in this application, sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT) which involves use of a portable medication dispenser that sends a signal to a server with the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting for clinical factors like degree of hepatic impairment and use of concomitant recreational and antiretroviral drugs. The goal is to quantify adherence in this population and the effect of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular, hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to identify a drug concentration biomarker that predicts adherence in this population. In Aim 3, the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations) and rate of cure will be established. The goal is to define the degree of adherence needed for HCV cure.

Condition or disease Intervention/treatment Phase
HEPATITIS C Virus, Human Immunodeficiency Behavioral: Directly Observed Therapy Behavioral: Wirelessly Observed Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Antiviral Pharmacology and Adherence in Drug Users
Study Start Date : November 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Arm Intervention/treatment
Sofosbuvir/Ledipasvir with Directly Observed Therapy (DOT)
Participants randomized to vDOT will be provided a smart phone with cellular service and will be pre-programmed with the mobile phone-based video application and contact information for study personnel.
Behavioral: Directly Observed Therapy
Other Name: DOT

Sofosbuvir/Ledipasvir with Wirelessly Observed Therapy (WOT)
Participants on WOT will be provided the Wisepill portable medication dispenser.
Behavioral: Wirelessly Observed Therapy
Other Name: WOT

Primary Outcome Measures :
  1. Compare each individual's modeled estimate of ledipasvir and metabolites of sofosbuvir (GS-331007 and GS-331007-TP) steady state concentrations (Css) from non-linear mixed effects modeling to Css in subjects receiving DOT vs. WOT. [ Time Frame: 12 weeks ]
  2. Quantify GS-331007-TP concentrations in dried blood spots as a function of adherence (doses taken/doses prescribed). [ Time Frame: 12 weeks ]
  3. Estimate the probability of HCV cure as a function of adherence using logistic regression. [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to give informed consent
  • HIV-infected men and women
  • Chronic HCV infection as documented by quantifiable HCV RNA
  • HCV genotype 1, 4, 5, 6
  • 18-70 years of age
  • Willingness and ability to comply with study procedures, including DOT, WOT, and biweekly clinic visits
  • Considered an active drug user by HCV provider and self-reported drug use within the past month

Exclusion Criteria:

  • Glomerular filtration rate < 30 mL/min/1.73 m2
  • Receipt of prior HCV treatment and radiographic, histologic, or clinical evidence of cirrhosis
  • Decompensated liver disease (i.e., ascites, history of esophageal variceal bleeding, hepatic encephalopathy)
  • Medications not recommended per the SOF/LDV prescribing information (e.g., tipranavir and other P-gp inducers, tenofovir disoproxil fumarate plus cobicistat, rosuvastatin, amiodarone)
  • Any medical condition that in the opinion of the investigators will make it challenging to adhere to the study protocol, such as unstable heart disease or cancer
  • Chronic Hepatitis B virus Infection
  • For females, active pregnancy or any intent to become pregnant
  • For both sexes, an unwillingness to use contraception during the study period
  • On parole or impending sentencing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02573376

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Contact: Ryan T Huntley, B.S. 303-724-5564
Contact: Jennifer J Kiser, PharmD 303-724-6131

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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Ryan T Huntley, BS    303-724-5564   
Sponsors and Collaborators
University of Colorado, Denver
Denver Health and Hospital Authority
National Institute on Drug Abuse (NIDA)
Gilead Sciences
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Principal Investigator: Jennifer J Kiser, PharmD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver Identifier: NCT02573376    
Other Study ID Numbers: 15-0809
1R01DA040499-01 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Keywords provided by University of Colorado, Denver:
Hepatitis C
Drug Abuse
Hepatitis C Virus
Additional relevant MeSH terms:
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Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases