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A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

NCT01939197 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2021-07-12

Study results available
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Summary

The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment.

Conditions

  • Hepatitis C Virus Infection
  • Human Immunodeficiency Virus Infection
  • Chronic Hepatitis C
  • Compensated Cirrhosis and Non-cirrhotics

Interventions

DRUG

ABT-450/r/ABT-267

tablet

DRUG

ABT-333

tablet

DRUG

ribavirin

tablet

Sponsors & Collaborators

Principal Investigators

  • Rolando Viani, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-30
Primary Completion
2016-07-21
Completion
2016-10-25

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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 NCT01939197 on ClinicalTrials.gov