Search / Trial NCT00000949

A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Aids Related Opportunistic Infections Interleukin 2 Dose Response Relationship, Drug Adolescent Behavior Cd4 Lymphocyte Count Rna, Viral Quality Of Life Anti Hiv Agents Viral Load

ClinConnect Summary

There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2.

Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Agree to practice abstinence or use effective birth control methods during the study.
  • Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3.
  • Are at least 18 years old.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have a history of progressive diseases.
  • Have a history of severe autoimmune/inflammatory disease.
  • Have Crohn's disease.
  • Are taking antiseizure medications or certain other medications.
  • Are receiving chemotherapy.
  • Are pregnant or breast-feeding.
  • Have ever received rIL-2.

Trial Officials

Donald I. Abrams

Study Chair

Norman Markowitz

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

San Francisco, California, United States

Denver, Colorado, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Philadelphia, Pennsylvania, United States

Washington, District Of Columbia, United States

Camden, New Jersey, United States

Portland, Oregon, United States

Albuquerque, New Mexico, United States

Detroit, Michigan, United States

New York, New York, United States

Richmond, Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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