Roche trials database

Trial information

A Study of PEGASYS (Peginterferon alfa-2a (40KD)) plus Ribavirin in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection, With and Without Highly Active Antiretroviral Therapy (HAART)

Status:

Terminated

Protocol number:

ML18562

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

A randomized, open-label study of the safety and tolerability of PEGASYS plus ribavirin in patients with chronic hepatitis C viral infection, genotype-1, and HIV-1 co-infection receiving, or discontinuing, highly active antiretroviral therapy (HAART)

Brief summary:

This study will compare the safety and tolerability of PEGASYS plus ribavirin in patients with CHC genotype-1 and HIV-1 co-infection receiving, or discontinuing, highly active antiretroviral therapy (HAART). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 4.

Study phase:

IV

Study type:

Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety study

Conditions:

• Hepatitis C, Chronic

Primary outcome:

1. Safety: Hemoglobin, neutrophil count and platelets, Child-Pugh Score, need to re-introduce antiretroviral therapy in the no-HAART arm, or initiate opportunistic infection prophylaxis in both groups, or to change therapy in the HAART arm; adverse events\n

Key secondary outcomes:

1. Efficacy: sustained virologic response at 72 weeks, HIV-1-RNA levels and CD4/CD8 cell counts up to 72 weeks\n

Inclusion criteria:

• adult patients >=18 years of age;
• CHC, genotype 1;
• compensated liver disease;
• stable HAART for >=12 weeks before study;
• chronic liver disease consistent with CHC.

Exclusion criteria:

• any previous treatment with an interferon, peginterferon, viramidine, levovirin, or ribavirin;
• active hepatitis B infection;
• medical condition associated with chronic liver disease other than CHC infection;
• decompensated liver disease;
• active HIV-related opportunistic infection or malignancy requiring acute systemic therapy.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

September, 2005

Trial registration date:

21.12.2005

Date last updated:

10.06.2013

This trial was conducted at the following locations:

Canada

• EDMONTON, AB
• OTTAWA, ON
• TORONTO, ON
• MONTREAL, QC

Link to trial result