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 Inc
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 100.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
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
Key secondary outcomes: 1. Efficacy: sustained virologic response at 72 weeks, HIV-1-RNA levels and CD4/CD8 cell counts up to 72 weeks
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
Trial registration date: 08/26/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Edmonton, AB
- Ottawa, ON
- Toronto, ON
- Montreal, QC
