Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

NCT03221309 | Completed Results

• 1 other identifier: HP-00071577
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

Conditions

HCV; Buprenorphine; PreP

Outcome Measures

Primary Outcomes (1)

• Hepatitis C Virus (HCV) Cure (Sustained Virologic Response)

  Undetectable HCV viral load 12 weeks after the end of treatment

  24 weeks

Secondary Outcomes (4)

• Uptake of HIV Pre-exposure Prophylaxis (PrEP)

  24 weeks

• Retention on HIV PrEP

  48 weeks

• Uptake of Buprenorphine

  24 weeks

• Retention in Buprenorphine Program

  48 weeks

Study Arms (1)

Adults infected with HCV

Phase 1 (first 100 enrolled participants) HCV-infected adults with on-going injection drug use use with opioids with 3 months of screening Phase 2 (enrolled participants 101-200) HCV-infected adults with on-going opioid misuse of non-prescription opioids within twelve months of screening

Other: Evaluate model of care for HCV-infected adults with on-going opioid misuse

Interventions

Evaluate model of care for HCV-infected adults with on-going opioid misuse OTHER

Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered PreP for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated

Adults infected with HCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults infected with HCV and have on-going misuse with opioids

You may qualify if:

• Age 18 years old
• Able and willing to sign informed consent
• Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
• Willing to have samples stored for future use
• Ongoing injection drug use, defined as self-report of either:
• Phase 1 (first 100 enrolled participants) Injection non-prescription drug use within three months of screening visit or
• Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within twelve months of screening visit

You may not qualify if:

• Decompensated liver disease (Childs Pugh B or C)
• Unable to comply with research study visits
• Poor venous access not allowing screening laboratory collection
• Have any condition that the investigator considers a contraindication to study participation
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

HIPS

Washington D.C., District of Columbia, 20002, United States

Location

University of Maryland Drug Treatment Center

Batlimore, Maryland, 21223, United States

Location

Related Publications (1)

• Rosenthal ES, Silk R, Mathur P, Gross C, Eyasu R, Nussdorf L, Hill K, Brokus C, D'Amore A, Sidique N, Bijole P, Jones M, Kier R, McCullough D, Sternberg D, Stafford K, Sun J, Masur H, Kottilil S, Kattakuzhy S. Concurrent Initiation of Hepatitis C and Opioid Use Disorder Treatment in People Who Inject Drugs. Clin Infect Dis. 2020 Oct 23;71(7):1715-1722. doi: 10.1093/cid/ciaa105.

  PMID: 32009165 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Limitations and Caveats

Study conducted at two urban sites, may not be generalizable to all populations.

Results Point of Contact

• Title: Dr. Elana Rosenthal / Associate Professor
• Organization: Institute of Human Virology, University of Maryland School of Medicine

erosenthal@ihv.umaryland.edu

2403674157

Study Officials

• Elana Rosenthal, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 18, 2017
• Study Start: May 1, 2017
• Primary Completion: January 22, 2021
• Study Completion: February 22, 2021
• Last Updated: May 4, 2026
• Results First Posted: September 3, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)