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

Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART

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.

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.