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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cytomegalovirus Infections

Drug Information available for: Ganciclovir Ganciclovir sodium Aldesleukin

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002321

Locations

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

Sponsors and Collaborators

Chiron Corporation

More Information

No publications provided

Study ID Numbers:	086A, CS-L293-10
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002321 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
Interleukin-2
Ganciclovir

Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antiviral Agents

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Antiviral Agents
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections

Virus Diseases
Aldesleukin
Anti-Retroviral Agents
Interleukin-2
HIV Infections
Sexually Transmitted Diseases
Cytomegalic Inclusion Disease
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Retinitis
Infection
Anti-Retroviral Agents
Therapeutic Uses
Cytomegalovirus Infections
Retroviridae Infections
Retinal Diseases
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Eye Infections, Viral

Eye Diseases
Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Eye Infections
Ganciclovir
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Aldesleukin
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 02, 2009