Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, Interleukin-2, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents
Brief summary
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.
Detailed description
Patients will receive subcutaneous Proleukin in combination with ganciclovir and antiretroviral therapy, and the MTD will be determined.
Interventions
DRUGAldesleukin
Sponsors
Chiron Corporation
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed