NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedN/A

Sponsor: University of Maryland, Baltimore

Conditions: HCV, Buprenorphine, PreP

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

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Age 18 years old
2. Able and willing to sign informed consent
3. 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).
4. Willing to have samples stored for future use
5. Ongoing injection drug use, defined as self-report of either:

   1. Phase 1 (first 100 enrolled participants) Injection non-prescription drug use within three months of screening visit or
   2. Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within twelve months of screening visit

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

Locations (2)

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