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

HIV Infections Clinical Trial

Official title:

Open, Multicentre and Randomised Phase IV Study to Evaluate Viral Kinetics in the First 12 Weeks of Patients With Chronic Hepatitis C Genotypes 1 and 4 Coinfected by the Human Immunodeficiency Virus Treated With Induction Doses of Peginterferon Alpha-2a (40 KD) (270 μg/Week) and Ribavirin (1600 mg/Day) With Epoetin β Support (450 IU/kg/Week)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356486
• Other study ID #: CORAL-2
• Secondary ID: 2004 - 000907 -1
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Est. completion date: March 2009

Study information

• Verified date: December 2019
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Germans Trias i Pujol, Badalona	Badalona	Barcelona
Spain	Hospital Clínic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañón.	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital de Donostia	San Sebastián	Donostia
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital General de Vic	Vic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with undetectable RNA-HCV		at week 12 after starting treatment
Secondary	Variations of the levels of RNA-HCV		from baseline until weeks 4, 8, and 12 of the study
Secondary	Percentage of patients with undetectable HCV RNA		in weeks 4 and 8 of the study
Secondary	Levels of ALT		At weeks 4, 8, and 12
Secondary	Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and ribavirin.		During the 12 weeks of follow-up
Secondary	Percentage of patients that drop out of the study for adverse effects or intolerance		During the 12 weeks of follow-up
Secondary	Variations in levels of haemoglobin, neutrophil, and platelet count		at 4, 8, and 12 weeks with regard to baseline
Secondary	AIDS-defining events or death		During the 12 weeks of follow-up
Secondary	Changes in the CD4/CD8 cell count		At 4, 8, and 12 weeks of follow-up