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NCT00002321 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002321
Other study ID # 086A
Secondary ID CS-L293-10
Status Completed
Phase Phase 1
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date October 1994
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aldesleukin

Locations
Country Name City State
United States Med College of Ohio Toledo Ohio

Sponsors (1)
Lead Sponsor Collaborator
Chiron Corporation

Country where clinical trial is conducted

United States, 

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