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.

Condition	Treatment or Intervention	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Aldesleukin	Phase I

Further Study Details: 

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Ohio
      Med College of Ohio, Toledo,  Ohio,  43699,  United States

Study ID Numbers:  086A; CS-L293-10
Record last reviewed:  October 1994
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002321
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08