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A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002107
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

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, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Brief summary

To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Detailed description

Patients will receive subcutaneous Proleukin, and the MTD will be determined.

Interventions

DRUGAldesleukin

Sponsors

Chiron Corporation
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients must have: * Documented HIV infection by ELISA and Western blot. * CD4 count \> 200 cells/mm3. Required: * FDA-approved antiretroviral therapy for at least 2 months prior to study entry.

Countries

United States

Outcome results

None listed

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