Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID: NCT00000821
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 78
Expected to finish: 2002-03-01
Last updated by the study team: 2021-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Natl Inst of Allergy & Infect Dis / Cln Ctr — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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