NCT00002321

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1994

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus RetinitisHIV Infections

Keywords

RetinitisInterleukin-2GanciclovirDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAntiviral Agents

Interventions

AldesleukinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med College of Ohio

Toledo, Ohio, 43699, United States

Location

MeSH Terms

Conditions

Cytomegalovirus RetinitisHIV InfectionsRetinitisMultiple Acyl Coenzyme A Dehydrogenase DeficiencyAcquired Immunodeficiency Syndrome

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsCytomegalovirus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesEye DiseasesRetinal DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1994-10

Locations

US(1)