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Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000821
  Purpose

To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.


Condition Intervention Phase
HIV Infections
Drug: Aldesleukin
Phase I

MedlinePlus related topics: AIDS
Drug Information available for: Aldesleukin Interleukin-2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 78
Detailed Description:

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.

Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV positivity.
  • CD4 count >= 500 cells/mm3.
  • No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma.

Concurrent Medication: Required:

  • Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T).

Prior Medication: Required:

  • FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Significant cardiac, pulmonary, thyroid, renal, or CNS disease.

Prior Medication:

Excluded:

  • Prior IL-2.
  • Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000821

Locations
United States, Maryland
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Click here for more information about Aldesleukin  This link exits the ClinicalTrials.gov site

Publications:
Giedlin M, McGrath M, Gascon R, DeGroat S, Fyfe G, Kahn J. Immunological characterization of HIV seropositive patients treated with subcutaneous Proleukin (aldesleukin) recombinant Interleukin-2. Int Conf AIDS. 1996 Jul 7-12;11(2):282 (abstract no ThB4183)
Davey RT Jr, Chaitt DG, Albert JM, Piscitelli SC, Kovacs JA, Walker RE, Falloon J, Polis MA, Metcalf JA, Masur H, Dewar R, Baseler M, Fyfe G, Giedlin MA, Lane HC. A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type 1 infection. J Infect Dis. 1999 Apr;179(4):849-58.

Study ID Numbers: IL-2 SC, IRP 015, 93-I-0205
Study First Received: November 2, 1999
Last Updated: July 30, 2008
ClinicalTrials.gov Identifier: NCT00000821  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interleukin-2
AIDS-Related Complex

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Aldesleukin
Interleukin-2
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009