Clinical Trial Protocol Registry
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)
- Protocol number:
- Hoffmann-La Roche
- Company division:
- 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:
- Study type:
- Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety study
- Hepatitis C, Chronic
- Primary outcome:
- 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:
- 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.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- September, 2005
- Trial registration date:
- Date last updated:
- EDMONTON, AB
- OTTAWA, ON
- TORONTO, ON
- MONTREAL, QC
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