Back to resultsA Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
Primary Purpose
Cytomegalovirus Retinitis, HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aldesleukin
Sponsored by
About this trial
This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Interleukin-2, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents
Eligibility 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.
Sites / Locations
- Med College of Ohio
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002321
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chiron Corporation
4. Oversight
5. Study Description
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.
Detailed Description
Patients will receive subcutaneous Proleukin in combination with ganciclovir and antiretroviral therapy, and the MTD will be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Interleukin-2, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aldesleukin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Med College of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43699
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs