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

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

• HIV positive

• History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI

• HIV RNA >400-<50,000 copies/mL

• Laboratory parameters: platelet count (75,000u/L, hemoglobin >9gm/dl, absolute neutrophil count >1,000/uL, SGOT/SGPT<5xULN.

Exclusion Criteria:

• Current ribavirin therapy

• Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention

• Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures

• Concomitant use of immunosuppressants or cytotoxic agents

• History of seizure disorder requiring use of anticonvulsants