NCT02897596

Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.

Detailed description

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir

Conditions

• Hepatitis C
• HIV

Interventions

Type	Name	Description
DRUG	Grazoprevir 100 mg/d 8 weeks	Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
DRUG	Elbasvir 50 mg/d 8 weeks	Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
DRUG	Grazoprevir 100 mg/d 12 weeks	Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
DRUG	Elbasvir 50 mg/d 12 weeks	Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.

Timeline

• Start date: 2017-04-28
• Primary completion: 2019-04-28
• Completion: 2019-10-30
• First posted: 2016-09-13
• Last updated: 2019-02-15

Locations

1 site across 1 country: Spain