Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV

NCT ID: NCT00356486

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-03-31

Brief Summary

The purpose of this study is to compare the early virological response (EVR = undetectable [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.

Detailed Description

This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week) and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of the product in the blood needed to reduce the half-life of the virions and accelerate the elimination thereof. This would bring the viral kinetic curves in coinfected patients closer to the model described for mono-infected HCV patients, probably achieving improved rates of response in week 12 (early virological response) and posterior in week 72 (sustained virological response).

Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180 µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Peginterferon alfa-2a (40 KD) (270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (40 KD) (180 µg/week) + Ribavirin (1000-1200 mg/day) for 8 weeks

Group Type: EXPERIMENTAL

Peginterferon alfa-2a, Ribavirin, epoetin-β

Intervention Type: DRUG

Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks

B

Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks

Group Type: EXPERIMENTAL

Peginterferon alfa-2a + Ribavirin for 12 weeks

Intervention Type: DRUG

Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks

Interventions

Peginterferon alfa-2a, Ribavirin, epoetin-β

Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks

Intervention Type: DRUG

Peginterferon alfa-2a + Ribavirin for 12 weeks

Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Serological evidence of chronic hepatitis C infection in an anti-HCV antibody test
• Detectable RNA-HCV plasma level genotype 1 and 4
• ALT serum activity above the upper limit of normality
• Chronic liver disease consistent with chronic hepatitis C infection in a biopsy obtained during the two years prior to inclusion in the study
• Serological evidence of HIV-1 infection, diagnosed by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed by Western-blot.
• Patients with CD4 cell count > 200 /µl
• Stable status in HIV-1 infection, in the investigator's opinion, in other words, patients that are not expected to progress during the study.
• Patients treated with stable anti-retroviral therapy (HAART), which does not include nucleoside analogues, for at least 6 weeks before the baseline assessment
• Patients that do not receive HAART therapy
• Negative pregnancy test in urine or blood

Exclusion Criteria

• Women currently pregnant or in the lactation period.
• Patients whose companion is pregnant.
• Therapy with interferon (IFN) or ribavirin at any previous time.
• Patients with cirrhosis in the hepatic biopsy.
• Documented suspicion by ultrasound of hepatocarcinoma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonaventura Clotet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

LLuita contra la Sida Foundation-HIV Unit

Locations

Hospital Germans Trias i Pujol, Badalona

Badalona, Barcelona, Spain

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Hospital General de Vic

Vic, Barcelona, Spain

Hospital de Donostia

San Sebastián, Donostia, Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Clínic i Provincial

Barcelona, , Spain

Hospital Puerta del Mar

Cadiz, , Spain

Hospital Gregorio Marañón.

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Countries

Spain

Other Identifiers

2004 - 000907 -16

Identifier Type: -

Identifier Source: secondary_id

CORAL-2

Identifier Type: -

Identifier Source: org_study_id