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PEG-Intron in HIV-Infected Subjects Failing HAART
NCT00005012Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2000
- Countries
- 2
- Sponsor
- Merck & Co.
- Modality
- Polymer-based Nanoparticles, Cytokines & Interferons
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 2, randomised, double-blind trial of peginterferon alfa-2b in human immunodeficiency virus infection (HIV) (5 arms), sponsored by Merck & Co. Primary endpoint: Decrease in HIV RNA at 4 weeks. Started Mar 2000; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
PEG-Intron Dose 1
PEG-Intron Dose 1 + Failing HAART
PEG-Intron Dose 2
PEG-Intron Dose 2 + Failing HAART
PEG-Intron Dose 3
PEG-Intron Dose 3 + Failing HAART
PEG-Intron Dose 4
PEG-Intron Dose 4 + Failing HAART
Placebo
Placebo + Failing HAART
03
Who it enrols
HIV-infected patients failing their current HAART regimen with viral load > 2000 copies/ml and CD4 > 200 cells/microL.
04
Endpoints
Primary
Decrease in HIV RNA
Secondary
Safety and Tolerability
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