Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002321
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
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
Sponsor:
Chiron Corporation
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
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
Status:
COMPLETED
Status Verified Date:
1994-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CS-L293-10 | None | None | None |