Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000769
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Phase III Study of Recombinant Interleukin-4 in AIDS and Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study of Recombinant Interleukin-4 in AIDS and Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2021-10
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 safety and tolerance of interleukin-4 IL-4 in patients with AIDS-related Kaposis sarcoma To determine the effects of IL-4 on tumor growth in patients with AIDS-related Kaposis sarcoma
IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor of Kaposis sarcoma cells in vitro
IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor of Kaposis sarcoma cells in vitro
Detailed Description:
IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor of Kaposis sarcoma cells in vitro
Patients are stratified into two groups according to CD4 count less than 100 cellsmm3 and greater than or equal to 100 cellsmm3 and are enrolled in cohorts of four patients at each of four dose levels of IL-4 per stratum Within each stratum if patients at a given dose level have received at least 2 weeks of study therapy and no more than two patients experienced grade 3 or 4 drug-related toxicity dose escalation in subsequent patients may begin The MTD is defined as the dose at which 50 percent of patients develop grade 3 or worse toxicity Patients with CD4 count less than 500 cellsmm3 per 123094 amendment must be on antiretroviral therapy during study treatment
PER AMENDMENT 112095 Group I - enrollment is closed the objective has been defined Group II - patients must have CD4 cells greater than or equal to 100mm3 and less than 500mm3
PER AMENDMENT 112095 All patients will receive antiretroviral therapy
Patients are stratified into two groups according to CD4 count less than 100 cellsmm3 and greater than or equal to 100 cellsmm3 and are enrolled in cohorts of four patients at each of four dose levels of IL-4 per stratum Within each stratum if patients at a given dose level have received at least 2 weeks of study therapy and no more than two patients experienced grade 3 or 4 drug-related toxicity dose escalation in subsequent patients may begin The MTD is defined as the dose at which 50 percent of patients develop grade 3 or worse toxicity Patients with CD4 count less than 500 cellsmm3 per 123094 amendment must be on antiretroviral therapy during study treatment
PER AMENDMENT 112095 Group I - enrollment is closed the objective has been defined Group II - patients must have CD4 cells greater than or equal to 100mm3 and less than 500mm3
PER AMENDMENT 112095 All patients will receive antiretroviral therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11201 | REGISTRY | DAIDS ES Registry Number | None |