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

Status and phase: Completed; Phase 1

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Aldesleukin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002321

086A

CS-L293-10

Details and patient eligibility

About

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.

Full description

Patients will receive subcutaneous Proleukin in combination with ganciclovir and antiretroviral therapy, 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 seropositivity.

Prior Medication:

Required:

• FDA-approved antiretroviral therapy for at least 2 months prior to study entry.

Allowed:

• Prior G-CSF.