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

C

Chiron Corporation

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Aldesleukin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002107
CS-L293-09
085A

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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