skip to content

Clinical Trials

MainTitle

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
Chiron Corporation


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002321

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: October 1994
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

More Information


Responsible Party: Chiron Corporation  
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
Aldesleukin
Interleukin-2
Ganciclovir
Ganciclovir triphosphate

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.