NCT00005012

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (planned)
• Sponsor: Schering-Plough · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2b

Timeline

• Start date: 2000-03-01
• Completion: 2000-09-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

22 sites across 2 countries: United States, Puerto Rico