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

Completed · Phase 1

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002321

Run by

Chiron Corporation

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Med College of Ohio — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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