Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000834
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Phase I Study of Methotrexate for HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of Methotrexate for HIV Infection
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 methotrexate in HIV-infected patients To determine the dose effective in modulating key markers of immune activation To determine a dose suitable for Phase II or III evaluation in HIV-infected patients
In HIV infection complete immunological clearance of the foreign antigen does not occur resulting in chronic immune activation Because chronic immune activation may contribute to disease progression in HIV infection immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect thus it may reduce the state of chronic immune activation
In HIV infection complete immunological clearance of the foreign antigen does not occur resulting in chronic immune activation Because chronic immune activation may contribute to disease progression in HIV infection immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect thus it may reduce the state of chronic immune activation
Detailed Description:
In HIV infection complete immunological clearance of the foreign antigen does not occur resulting in chronic immune activation Because chronic immune activation may contribute to disease progression in HIV infection immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect thus it may reduce the state of chronic immune activation
Patients are randomized to receive methotrexate at Dose 1 or 2 low doses for 12 weeks with 8 weeks of follow-up If interim safety monitoring and viral burden results for the two cohorts support continuation a third cohort of patients receive methotrexate starting at Dose 2 for the first 2 weeks then at Dose 3 for the next 2 weeks and at Dose 4 for the remaining 8 weeks with 8 weeks of follow-up
AS PER AMENDMENT 11097
The Dose 1 the lowest dose has been eliminated the first 10 patients are now assigned to the next higher dose Depending upon the results of interim safety data the next cohort will be entered on the escalating dose regimen
Also per this amendment all patients will receive zidovudine and lamivudine for 30 days prior to the initiation of methotrexate during the 12 weeks of methotrexate administration and for the 8 weeks of follow-up
Patients are randomized to receive methotrexate at Dose 1 or 2 low doses for 12 weeks with 8 weeks of follow-up If interim safety monitoring and viral burden results for the two cohorts support continuation a third cohort of patients receive methotrexate starting at Dose 2 for the first 2 weeks then at Dose 3 for the next 2 weeks and at Dose 4 for the remaining 8 weeks with 8 weeks of follow-up
AS PER AMENDMENT 11097
The Dose 1 the lowest dose has been eliminated the first 10 patients are now assigned to the next higher dose Depending upon the results of interim safety data the next cohort will be entered on the escalating dose regimen
Also per this amendment all patients will receive zidovudine and lamivudine for 30 days prior to the initiation of methotrexate during the 12 weeks of methotrexate administration and for the 8 weeks of follow-up
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 |
|---|---|---|---|
| 11742 | REGISTRY | DAIDS ES Registry Number | None |