Safety and Effectiveness of PEG-Intron in HIV-Infected Patients

Schering-Plough250 enrolled

Overview

The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).

At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

250

Conditions

HIV Infections

Interventions

Peginterferon alfa-2bDRUG

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients may be eligible for this study if they: * Have HIV levels of more than 2000 copies/ml. * Have failed their current HAART (had a significant increase in their HIV levels with HAART). * Have a CD4 cell count greater than 200 cells/microL. * Have had more than 6 months of HAART. * Have been on their current HAART for at least 6 weeks. * Agree to use an effective method of birth control during the study. Exclusion Criteria Patients will not be eligible for this study if they: * Have a history of a serious mental disorder. * Are allergic to interferons. * Are pregnant or breast-feeding. * Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.

Locations (22)

East Bay AIDS Ctr

Berkeley, California, United States

Data from ClinicalTrials.gov

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