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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

This study has been completed.

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   

U.S. FDA Resources

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

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


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

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
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Virus Diseases
Aldesleukin
Interleukin-2
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Eye Infections, Viral
Antineoplastic Agents
Infection
Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008




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