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DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)

NCT03537196 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 979

Last updated 2023-10-26

No results posted yet for this study

Summary

The study aims to assess the effectiveness of a model of hepatitis C screening and integrated care, targeting people who inject drugs (PWIDs) in Hai Phong, Vietnam. In a wider perspective, this model linked to mass screening through repeated Respondent Driven Sampling (RDS) surveys, to simplified treatment protocol, and to large community-based support to improve referral to care, retention in care, adherence to treatment and prevention of reinfection, may have the potential to eliminate HCV among PWIDs in this city.

Conditions

  • Hepatitis C
  • Drug Use
  • Viral Hepatitis C

Interventions

DRUG

Sofosbuvir 400 mg and Daclatasvir 60 mg

All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.

DRUG

Sofosbuvir 400 mg and Daclatasvir 90 mg

For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.

DRUG

Ribavirin

In case of cirrhosis: * Ribavirin will be added to sofosbuvir/daclatasvir during the 12 weeks of treatment. The dose will be adapted to the patient weight although the vast majority of patients (weight \< 75 kg) will receive 500 mg x 2/day. * In case of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.

DRUG

Sofosbuvir and Daclatasvir for 24 weeks

In case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • KHUE M. PHAM, MD, PhD · Hai Phong University of Medicine and Pharmacy, Vietnam

  • DIDIER LAUREILLARD, MD · Nîmes University Hospital, France

  • NICOLAS NAGOT, MD, PhD · Pathogenesis and Control of Chronic Infections (PCCI) UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2020-11-30
Completion
2022-12-30

Countries

  • Vietnam

Study Locations

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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 NCT03537196 on ClinicalTrials.gov