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Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy

NCT03549312 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-12-24

No results posted yet for this study

Summary

The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current antiretroviral therapy to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF, Genvoya™) followed by 12 weeks of HCV antiviral therapy with sofosbuvir/velpatasvir (SOF/VEL, Epclusa™), followed then by switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, Biktarvy™) for an additional 48 weeks.

Conditions

  • HIV-1-infection
  • Hepatitis C, Chronic
  • Methadone Dependence
  • Opioid Dependence
  • Bone Diseases, Metabolic
  • HIV/AIDS
  • Co-infection
  • Buprenorphine Dependence
  • HCV Coinfection

Interventions

DRUG

Genvoya

Switching to Genvoya for 48 weeks in patients with HIV/HCV co-infection and stably suppressed HIV RNA, prior to starting HCV treatment, while receiving methadone or buprenorphine/naloxone as opioid substitution therapy. Plasma HIV-1 RNA \< 50 copies/mL at weeks 4, 12, 24, 36 and 48.

DRUG

Epclusa

HCV therapy with direct-acting-antiviral therapy with Epclusa in HIV-HCV co-infected patients with suppressed HIV RNA, receiving methadone as opioid substitution therapy. Plasma HCV RNA viral load at weeks 12, 24, 36, 48, 72 and 96.

DRUG

Biktarvy

Switching to Biktarvy for 48 weeks in patients with HIV previously treated with Genvoya, stably supressed HIV RNA, while receiving methadone or buprenorphine/naloxone as opioid substitution therapy. Plasma HIV-1 RNA \< 50 copies/mL at weeks 52, 60, 72, 84 and 96.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Saskatchewan Health Authority - Regina Area

    lead OTHER

Principal Investigators

  • Alexander Wong, MD · Saskatchewan Health Authority - Regina Area

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-07-21
Completion
2021-06-22
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549312 on ClinicalTrials.gov