PHASE III STUDY OF PEG-INTRON IN PATIENTS INFECTED BY HIV WHO HAVE EXPERIENCED MULTIPLE TREATMENTS

Not Applicable

• Registration Number: PER-032-02
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-04-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

HIV positive; history of virological failure in at least 2 antiretroviral regimens including exposure to at least one nudeoside reverse transcriptase inhibitor, a non-nudeide reverse transcriptase inhibitor, and a protease inhibitor; > 400 and <50,000 copies / mL of HIV RNA at the time of entering the study with optimized antimetroviral therapy prior to initiation 2-6 months before incorporation; laboratory parameters; platelet count> 75,000 u / L, hemoglobin> 9 gm / dL, absolute neutrophil count> 1000 / uL.

Exclusion Criteria

Current treatment with ribavirin; Subjects with a diagnosis or history of moderate or severe depression that requires current psychiatric intervention.
Women of childbearing age who are breastfeeding, pregnant or not use adequate contraception; concomitant use of immunosuppressants or cytotoxic agents; a history of seizures that require the use of anticonvulsants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified