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| Sponsored by: |
Chiron Corporation |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002321 |
Purpose
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 | Intervention | Phase |
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Aldesleukin |
Phase I |
| MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
| Drug Information available for: | Ganciclovir Ganciclovir sodium Aldesleukin Interleukin-2 |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Safety Study |
| 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 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Documented HIV seropositivity.
Prior Medication:
Required:
Allowed:
Contacts and Locations More Information
| Study ID Numbers: | 086A, CS-L293-10 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002321 |
| Health Authority: | United States: Food and Drug Administration |
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