Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000899
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study on the Effect of Chemotherapy Combined With Anti-HIV Drugs in HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effect of Cytoreductive Chemotherapy Combined With Highly Active Antiretroviral Therapy on Lymph Node HIV DNA in HIV-Infected Subjects
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:
The purpose of this study is to determine the safety of anti-HIV drugs combined with low-dose chemotherapy consisting of cyclophosphamide CTX in HIV-positive patients This study examines whether this combination therapy can reduce the number of HIV-infected cells hidden in the lymph nodes and blood
Current anti-HIV drug treatments can greatly reduce the levels of HIV in the human body However HIV can hide in certain immune cells and escape the drugs effects Chemotherapy using CTX destroys these immune cells When used with standard anti-HIV drug treatments CTX may be able to speed up the elimination of HIV-infected cells
Current anti-HIV drug treatments can greatly reduce the levels of HIV in the human body However HIV can hide in certain immune cells and escape the drugs effects Chemotherapy using CTX destroys these immune cells When used with standard anti-HIV drug treatments CTX may be able to speed up the elimination of HIV-infected cells
Detailed Description:
HAART is a potent suppressor of plasma and lymph node HIV RNA However studies suggest that HAART cannot significantly diminish reservoirs of chronically HIV-infected cells Strategies designed to eradicate all HIV infection should seek to actively target these reservoirs CTX administration has been shown to eliminate a large number of lymphoid tissue T cells and macrophages appearing to actively target chronically HIV-infected cells As lymphoid organs are repopulated following initial depletion with CTX HAART may protect repopulating cells from becoming HIV-infected resulting in a net additional removal of the HIV-infected lymphoid reservoir
In Step 1 of this 2-step protocol all patients receive a HAART regimen of nelfinavir NFV plus stavudine d4T plus lamivudine 3TC Patients who achieve an acceptable virologic response defined as 2 consecutive HIV RNA determinations below 500 copiesml at least 2 weeks apart between Weeks 4 and 16 of Step 1 AS PER AMENDMENT 103098 defined as 2 consecutive plasma HIV RNA determinations below 50 copiesml by the Roche Ultrasensitive assay within a 4-week period between Weeks 4 and 24 are randomized to Arm A or B of Step 2 In Arm A patients receive NFV plus d4T plus 3TC In Arm B patients receive NFV plus d4T plus 3TC plus 3 escalating doses of CTX at 6-week intervals Patients in both arms are followed for at least 52 weeks following randomization to Step 2 During this time patients undergo blood tests and lymph node biopsies to measure HIV DNA and RNA levels and to characterize the T cell population Additionally patients undergo a chest CT of the thymus before randomization to Step 2 and at Week 52 of Step 2 Cerebrospinal fluid may be obtained at Week 52 to determine the amount of HIV RNA and DNA present AS PER AMENDMENT 103098 G-CSF is given after the first dose of CTX at the discretion of the investigator and after the second and third doses for up to 14 days until the absolute neutrophil count is 10000 cellsmm3 Also CTX doses may be modified based on pharmacokinetic study results
In Step 1 of this 2-step protocol all patients receive a HAART regimen of nelfinavir NFV plus stavudine d4T plus lamivudine 3TC Patients who achieve an acceptable virologic response defined as 2 consecutive HIV RNA determinations below 500 copiesml at least 2 weeks apart between Weeks 4 and 16 of Step 1 AS PER AMENDMENT 103098 defined as 2 consecutive plasma HIV RNA determinations below 50 copiesml by the Roche Ultrasensitive assay within a 4-week period between Weeks 4 and 24 are randomized to Arm A or B of Step 2 In Arm A patients receive NFV plus d4T plus 3TC In Arm B patients receive NFV plus d4T plus 3TC plus 3 escalating doses of CTX at 6-week intervals Patients in both arms are followed for at least 52 weeks following randomization to Step 2 During this time patients undergo blood tests and lymph node biopsies to measure HIV DNA and RNA levels and to characterize the T cell population Additionally patients undergo a chest CT of the thymus before randomization to Step 2 and at Week 52 of Step 2 Cerebrospinal fluid may be obtained at Week 52 to determine the amount of HIV RNA and DNA present AS PER AMENDMENT 103098 G-CSF is given after the first dose of CTX at the discretion of the investigator and after the second and third doses for up to 14 days until the absolute neutrophil count is 10000 cellsmm3 Also CTX doses may be modified based on pharmacokinetic study results
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 |
|---|---|---|---|
| 11341 | REGISTRY | DAIDS ES | None |