Status:

COMPLETED

Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system tha...

Detailed Description

Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in an increased CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving larg...

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a CD4 cell count greater than or equal to 300 cells/mm3.
  • Have no AIDS-defining illnesses.
  • Are at least 18 years old.
  • Have been on antiretroviral therapy for at least 7 days prior to study entry.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
  • Have a history of cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease.
  • Are pregnant or breast-feeding.
  • Have ever received IL-2.

Key Trial Info

Start Date :

February 1 1998

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT00000948

Start Date

February 1 1998

Last Update

October 29 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Chulalongkorn Univ. Hosp. C603-010 CRS

Bangkok, Ratchathewi, Thailand

2

Siriraj Hospital C603-020 CRS

Bangkok, Ratchathewi, Thailand