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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.
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
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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:


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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00002321     History of Changes
Other Study ID Numbers: 086A
CS-L293-10
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis
Interleukin-2
Ganciclovir
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Retinitis
Cytomegalovirus Retinitis
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Aldesleukin
Interleukin-2
Ganciclovir
Ganciclovir triphosphate
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on July 21, 2017