Search / Trial NCT00000825

The 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

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

Trial Information

Current as of December 06, 2024

Completed

Keywords

Hiv 1 Interleukin 2 Dose Response Relationship, Drug Antiviral Agents Cd4 Lymphocyte Count Dna, Viral

ClinConnect Summary

IL-2, administered subcutaneously in combination with antiretrovirals, has resulted in increased CD4+ cell counts which may retard HIV disease progression. Using a smaller patient sampling, this Phase II study helps develop the clinical experience needed to consider formation of a larger, more complete Phase III trial.

Seventy-two HIV-infected patients (previously treated or naive) are randomized independently to receive either control therapy with antiretrovirals alone OR escalating doses of subcutaneous interleukin-2 (IL-2) plus antiretrovirals. In the absence of dose-limiting toxicity (...

Gender

ALL

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 the following: 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.

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

Houston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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