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

• Status: Completed
• Trial end date: 2000-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Schering-Plough
• Treatments: Peginterferon alfa-2b

Criteria

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.