A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis

Chiron Corporation

Overview

To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of Proleukin on the time to progression of CMV retinitis in patients being treated with therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Patients will receive subcutaneous Proleukin in combination with ganciclovir and antiretroviral therapy, and the MTD will be determined.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Cytomegalovirus Retinitis HIV Infections

Interventions

AldesleukinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: Documented HIV seropositivity. Prior Medication: Required: * FDA-approved antiretroviral therapy for at least 2 months prior to study entry. Allowed: * Prior G-CSF.

Locations (1)

Med College of Ohio

Toledo, Ohio, United States

Data from ClinicalTrials.gov

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