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

NCT00000821 | Completed Phase 1

• 3 other identifiers: IRP 015IL-2 SC93-I-0205
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Interleukin-2; AIDS-Related Complex

Interventions

Aldesleukin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Natl Inst of Allergy & Infect Dis / Cln Ctr

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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)

  BACKGROUND

• 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. doi: 10.1086/314678.

  PMID: 10068580 BACKGROUND

MeSH Terms

Conditions

HIV Infections; AIDS-Related Complex

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 2002
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)