Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000711
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
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 administer colony-stimulating factor GM-CSF for 4 weeks to AIDS and advanced AIDS related complex ARC patients who have been receiving zidovudine AZT therapy in order to obtain data on short-term effectiveness safety toxicity pharmacokinetics and tolerance of combined treatment with the two drugs
Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness These individuals could therefore benefit from therapy with an effective antiretroviral agent AZT which is a powerful inhibitor of human retrovirus has been approved for management of patients with symptomatic HIV infection GM-CSF not only stimulates the bone marrow it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro test tube Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection
Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness These individuals could therefore benefit from therapy with an effective antiretroviral agent AZT which is a powerful inhibitor of human retrovirus has been approved for management of patients with symptomatic HIV infection GM-CSF not only stimulates the bone marrow it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro test tube Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection
Detailed Description:
Persons infected with HIV virus may undergo a long latency or persistent virus blood levels which may be present before any symptomatic illness These individuals could therefore benefit from therapy with an effective antiretroviral agent AZT which is a powerful inhibitor of human retrovirus has been approved for management of patients with symptomatic HIV infection GM-CSF not only stimulates the bone marrow it enhances the function of mature blood cells and has been found to enhance the ability of AZT to suppress HIV replication in vitro test tube Combination therapy with GM-CSF and AZT may lower complications as well as the morbidity and mortality associated with HIV infection
Colony stimulating factor GM-CSF is administered subcutaneously once a day or every other day for 4 weeks to AIDS and advanced ARC patients who have been receiving and will continue to receive a constant dose of AZT Treatment is on an outpatient basis
Colony stimulating factor GM-CSF is administered subcutaneously once a day or every other day for 4 weeks to AIDS and advanced ARC patients who have been receiving and will continue to receive a constant dose of AZT Treatment is on an outpatient basis
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 |
|---|---|---|---|
| 11039 | REGISTRY | DAIDS ES Registry Number | None |