drugset / Trial / NCT00035360

Phase III PEG-Intron in HIV-infected Patients (Study P00738)

NCT00035360

Phase 3 Completed 49 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.

Timeline

Start
2002-03
Primary completion
2003-10
Completion
2003-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 1 ug/kg
Subject Peginterferon alfa-2b Protein / enzyme biologic 3 ug/kg

Indications