Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior
Completed
Conditions studied: HCV, Buprenorphine, PreP
In brief
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.
Key facts
- Study ID
- NCT03221309
- Run by
- University of Maryland, Baltimore
- People needed
- 198
- Starts
- 2017-05-01
- Expected to finish
- 2021-02-22
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- HIPS — Washington D.C., District of Columbia, United States
- University of Maryland Drug Treatment Center — Batlimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.