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.
Status: No longer recruiting
Protocol number: ML18473
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the effect of 48 and 72 weeks of treatment with PEGASYS plus ribavirin on sustained virological response in patients with chronic hepatitis C genotype 1 and HIV-1 co-infection.
Brief summary: This study will compare the efficacy and safety of 48 and 72 weeks' treatment with PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily), followed by 24 treatment-free weeks, in patients with CHC genotype co-infected with HIV-1. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is
180.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a[PEGASYS]
Primary outcome: 1. Sustained virological response (% with undetectable HCV-RNA) at 24 weeks' post-completion of 48 or 72 weeks treatment
Key secondary outcomes: 1. Efficacy:% patients with undetectable HCV-RNA up to 48/72 weeks of treatment; levels of HIV-RNA, CD4, CD8, ALT, up to week 72/96. Safety: AEs, laboratory abnormalities, AIDS-defining events
Inclusion criteria:
- adult patients >=18 years of age;
- CHC, genotype 1;
- chronic liver disease consistent with CHC;
- compensated liver disease;
- stable HIV-1 infection;
- patients on stable HAART for at least 6 weeks prior to baseline, or patients who have not been on HAART for at least 8 weeks prior to baseline.
Exclusion criteria:
- any previous treatment with an interferon or ribavirin;
- medical condition associated with chronic liver disease other than CHC infection;
- decompensated liver disease;
- active HIV-related opportunistic infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2006
Trial registration date: 03/30/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
- Campinas
- Florianopolis
- Itajaí
- Juiz De Fora
- Porto Alegre
- Recife
- Ribeirão Preto
- Rio De Janeiro
- Rio Grande
- Santo Andre
- Santos
- Sao Paulo
