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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002321
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1994

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002321 on ClinicalTrials.gov Archive Site
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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
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

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.

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

Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Aldesleukin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002321
086A, CS-L293-10
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Chiron Corporation
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NIH AIDS Clinical Trials Information Service
October 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP