Trial intelligence / Profile preview

Proleukin in HIV-1 Infection with CD4 >= 300

NCT00000949Phase 3

Key facts

Status
Completed
Countries
1
Sponsor
National Institute of Allergy and Infectious Diseases
Modality
Cytokines & Interferons
Conditions
human immunodeficiency virus infection (HIV)
01

Overview

Phase 3, randomised, open-label trial of aldesleukin in human immunodeficiency virus infection (HIV) (3 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: HIV Viral Burden and CD4+ Cell Count. Status: completed.

02

Design

3 arms
Study design
RandomizedOpen-label
  • rIL-2 Dose 1

    Subcutaneous rIL-2 Dose 1 + Anti-HIV therapy

  • rIL-2 Dose 2

    Subcutaneous rIL-2 Dose 2 + Anti-HIV therapy

  • Control

    Anti-HIV therapy alone

03

Who it enrols

HIV-positive adults with CD4 count >= 300 cells/mm3 on anti-HIV therapy. Excludes patients with history of progressive diseases, severe autoimmune/inflammatory disease, Crohn's disease, or prior rIL-2 therapy.

04

Endpoints

Primary

  • HIV Viral Burden

  • CD4+ Cell Count

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