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
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections
Intervention: Aldesleukin (Drug)
Phase: Phase 1
Sponsored by: Chiron Corporation
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
Official title: 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
Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment
Patients will receive subcutaneous Proleukin in combination with ganciclovir and
antiretroviral therapy, and the MTD will be determined.
Minimum age: 18 Years.
Maximum age: N/A.
Patients must have:
Documented HIV seropositivity.
- FDA-approved antiretroviral therapy for at least 2 months prior to study entry.
- Prior G-CSF.
Locations and Contacts
Med College of Ohio, Toledo, Ohio 43699, United States
Last updated: June 23, 2005