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A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

NCT01783678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2015-04-30

Study results available
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Summary

This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

Conditions

  • Chronic Hepatitis C
  • Human Immunodeficiency Virus

Interventions

DRUG

Sofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors & Collaborators

Principal Investigators

  • Anuj Gaggar, MD, PhD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-04-30
Completion
2014-07-31

Countries

  • Australia
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01783678 on ClinicalTrials.gov