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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000821

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

2002-03-31

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Interleukin-2, AIDS-Related Complex

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.

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.

Interventions

DRUGAldesleukin

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026