Trial information
PERFECT Study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis C (CHC) and Human Immunodeficiency Virus (HIV) Co-infection, Not Responding to PEGASYS Plus Ribavirin
Status: No longer recruiting
Protocol number: ML18234
Sponsor: N.V. Roche S.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label pilot study of the safety and tolerability of maintenance treatment with low-dose PEGASYS monotherapy in patients with chronic hepatitis C viral infection and HIV co-infection not responding to short-term treatment with PEGASYS plus ribavirin
Brief summary: This study will evaluate the efficacy and safety of maintenance treatment with low-dose PEGASYS monotherapy in patients with CHC and HIV co-infection not responding to short-term treatment with PEGASYS plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Target sample size is
20.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Safety: Adverse event rate and profile, HIV viral load and CD4 cell count, hematology and other laboratory tests
Key secondary outcomes: 1. Efficacy: Histologic response rate, biochemical response rate, and virologic response rate
Inclusion criteria:
- adult patients >=18 years of age;
- CHC;
- treatment with PEGASYS plus ribavirin for >=12 weeks without a positive effect;
- patients with CD4 count >=100cells/muL, and with stable HIV infection;
- if on antiretroviral therapy (highly active antiretroviral therapy [HAART]), must be on same drug and dosage for >=6 weeks before study;
- compensated liver disease.
Exclusion criteria:
- antineoplastic or immunomodulatory treatment <=6 months prior to first dose of study drug;
- chronic liver disease not associated with CHC infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2005
Trial registration date: 08/29/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Bruxelles
- Charleroi
- Edegem
- Gent
