Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031070
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2002-02-20
Brief Title:
Increasing HAART-Induced Immune Restoration With Cyclosporine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Augmenting the Magnitude of HAART-Induced Immune Restoration With the Use of Cyclosporine
Status:
COMPLETED
Status Verified Date:
2006-08
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 see if cyclosporine taken when a patient begins highly active antiretroviral therapy HAART increases the number of CD4 T-cells blood cells that fight infection in a patients blood This study also will explore the safety of briefly giving cyclosporine to patients starting HAART
Detailed Description:
The availability of HAART has substantially decreased the morbidity and mortality caused by HIV-1 infection There is clinical and laboratory evidence suggesting that treatment of HIV-1 infection not only arrests the progressive immune deterioration caused by HIV-1 but also is associated with at least partial immune reconstitution After starting HAART most patients with chronic HIV-1 infection experience an increase in CD4 T-cells but the magnitude of CD4 lymphocyte rise is highly variable Patients who do not experience a substantial rise in circulating CD4 lymphocytes remain at risk for opportunistic infections Strategies to enhance immune restoration in HIV-1 disease are needed Studies have shown that immune restoration after HAART in patients with chronic HIV-1 infection is incomplete There are however several potential methods that can be used that possibly may enhance the magnitude of CD4 lymphocyte rise induced by HAART It is proposed that the lymphoid tissues in which lymphocytes are trapped and activated to die are a major site of immunopathology and cellular losses in HIV-infection Interference with lymphocyte trapping and death in lymphoid tissues when cyclosporine an immunosuppressant is administered at the time of initiation of HAART may result in an enhancement of the magnitude of cellular restoration in patients who initiate HAART
Patients are randomized to 1 of 2 treatment arms
Arm A Weeks 1 to 2 abacavir ABClamivudine 3TCzidovudine ZDV Weeks 3 to 48 ABC3TCZDV and efavirenz EFV
Arm B Weeks 1 to 2 ABC3TCZDV and cyclosporine Weeks 3 to 48 ABC3TCZDV and EFV
Patients in both arms receive the following immunizations Weeks 8 and 12 Hepatitis A vaccine inactivated and rabies vaccine
Week 16 Rabies vaccine To ascertain whether the augmentation in the rise in CD4 lymphocytes is sustained the number of circulating CD4 lymphocytes 48 weeks after starting therapy is compared To examine the functional significance of the cellular increases the ability of patients to respond to immunization with recall and neoantigens are compared between the cyclosporine plus HAART arm and the HAART alone arm
Substudy A5139 A 2-week substudy designed to explore the mechanisms of first-phase cellular restoration is performed Patients undergo 4 lymph node aspirates Lymphocytes are analyzed by the use of flow cytometry and correlated with findings in the main study There is no limit on patient enrollment Patients register to the substudy immediately after randomizing to the main study
Patients are randomized to 1 of 2 treatment arms
Arm A Weeks 1 to 2 abacavir ABClamivudine 3TCzidovudine ZDV Weeks 3 to 48 ABC3TCZDV and efavirenz EFV
Arm B Weeks 1 to 2 ABC3TCZDV and cyclosporine Weeks 3 to 48 ABC3TCZDV and EFV
Patients in both arms receive the following immunizations Weeks 8 and 12 Hepatitis A vaccine inactivated and rabies vaccine
Week 16 Rabies vaccine To ascertain whether the augmentation in the rise in CD4 lymphocytes is sustained the number of circulating CD4 lymphocytes 48 weeks after starting therapy is compared To examine the functional significance of the cellular increases the ability of patients to respond to immunization with recall and neoantigens are compared between the cyclosporine plus HAART arm and the HAART alone arm
Substudy A5139 A 2-week substudy designed to explore the mechanisms of first-phase cellular restoration is performed Patients undergo 4 lymph node aspirates Lymphocytes are analyzed by the use of flow cytometry and correlated with findings in the main study There is no limit on patient enrollment Patients register to the substudy immediately after randomizing to the main study
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 |
|---|---|---|---|
| AACTG A5139s | None | None | None |
| AACTG A5138 | None | None | None |
| ACTG A5139s | None | None | None |