Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009009
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-01-20
Brief Title:
Kidney Transplant for HIV-Infected Patients in Renal Failure
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Renal Allotransplantation for Treatment of End Stage Renal Disease in the Setting of Human Immunodeficiency Virus HIV Infection
Status:
COMPLETED
Status Verified Date:
2002-12
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:
This study will examine the safety and effectiveness of renal kidney transplantation for HIV-infected patients with end-stage renal disease kidney failure Although kidney transplant is the best treatment for most causes of kidney failure people infected with HIV are not offered this procedure because the immunosuppressive drugs drugs that suppress immune function required to prevent organ rejection could further impair the patients already weakened immune system This study will use a regimen of immunosuppressants designed to complement treatment for patients taking highly active antiretroviral therapy HAART
HIV-infected patients between 18 and 60 years of age with renal failure who have not had any opportunistic infections for 5 years may be eligible for this study Candidates will be screened with a medical history physical examination and blood and urine tests
Before the transplant procedure participants will undergo additional tests and procedures including blood studies 24-hour urine collection infectious disease consultation tuberculin skin test PAP smear for women chest X-ray brain and hip MRI studies and DEXA-scan to evaluate bone density In addition patients may undergo leukapheresis to obtain white blood cells for study For this procedure whole blood is drawn through a needle in an arm vein and passed through a cell separator machine The white cells are collected for removal and the rest of the blood is returned to the body through the same needle or another needle in the other arm
When a donor organ becomes available for transplant the patient will receive three anti-rejection drugs-cyclosporine mycophenolate mofetil and prednisone-to prevent organ rejection Immediately after the surgery HAART drugs will be stopped for 7 days until stable levels of the immune suppressants can be achieved Then HAART will be re-started and all medications will be adjusted to achieve adequate blood levels Patients must stay in the local area 60 days after discharge from the hospital for monitoring Frequent blood samples will be taken to monitor kidney function viral load and CD4 T cell counts Follow-up visits will then be scheduled monthly for the first 6 months after transplant then every other month for 1 year Kidney biopsies will be done at the end of the first month after 6 months and yearly for 5 years For the biopsy a special needle is used to remove a small piece of kidney tissue for microscopic examination The biopsies and blood tests are done to evaluate the immune response to the transplanted organ and to study how HAART interacts with the immune suppressing drugs
HIV-infected patients between 18 and 60 years of age with renal failure who have not had any opportunistic infections for 5 years may be eligible for this study Candidates will be screened with a medical history physical examination and blood and urine tests
Before the transplant procedure participants will undergo additional tests and procedures including blood studies 24-hour urine collection infectious disease consultation tuberculin skin test PAP smear for women chest X-ray brain and hip MRI studies and DEXA-scan to evaluate bone density In addition patients may undergo leukapheresis to obtain white blood cells for study For this procedure whole blood is drawn through a needle in an arm vein and passed through a cell separator machine The white cells are collected for removal and the rest of the blood is returned to the body through the same needle or another needle in the other arm
When a donor organ becomes available for transplant the patient will receive three anti-rejection drugs-cyclosporine mycophenolate mofetil and prednisone-to prevent organ rejection Immediately after the surgery HAART drugs will be stopped for 7 days until stable levels of the immune suppressants can be achieved Then HAART will be re-started and all medications will be adjusted to achieve adequate blood levels Patients must stay in the local area 60 days after discharge from the hospital for monitoring Frequent blood samples will be taken to monitor kidney function viral load and CD4 T cell counts Follow-up visits will then be scheduled monthly for the first 6 months after transplant then every other month for 1 year Kidney biopsies will be done at the end of the first month after 6 months and yearly for 5 years For the biopsy a special needle is used to remove a small piece of kidney tissue for microscopic examination The biopsies and blood tests are done to evaluate the immune response to the transplanted organ and to study how HAART interacts with the immune suppressing drugs
Detailed Description:
Renal allotransplantation is the treatment of choice for most causes of end-stage renal disease ESRD However successful transplantation is dependent on the use of potent immunosuppressive drugs to prevent immune mediated rejection of the transplanted organ Patients who have become infected with the Human Immunodeficiency Virus HIV have an underlying immune deficit resulting primarily from the viruss affect on CD4 T lymphocytes Many of these individuals also develop ESRD However patients with HIV infection have been excluded from allotransplantation This has been based on the premise that the immune suppression required for transplantation would adversely affect their already compromised immune system Recently the treatment of HIV infection has improved dramatically particularly with the advent of protease inhibitors PI and their inclusion in highly active anti-retroviral therapy HAART protocols Additionally some immunosuppressant drugs have actually been shown to limit the replication and spread of HIV in vitro Thus the treatment of HIV associated ESRD with allotransplantation may be feasible
This protocol is a pilot trial investigating the potential utility of renal transplantation to treat ESRD in patients infected with HIV Ten patients with controlled HIV infection will receive renal allografts under an immunosuppressive regimen designed to complement HAART protocols Immune system monitoring will be performed specifically to evaluate the effect of immunosuppressive drugs on the T cell function and viral burden of allograft recipients The allograft will be periodically evaluated to assess the prevalence of disease recurrence or rejection Pharmacokinetic evaluation will be performed to define the interactions between HAART and immunosuppressive drug regimens Long-term outcome will be assessed at 1 and 5 years and compared to contemporaneous outcomes for non-infected patients receiving the standard of care It is hoped that this protocol will suggest ways of providing HIV infected patients with renal replacement therapy without jeopardizing their control over their viral infection
This protocol is a pilot trial investigating the potential utility of renal transplantation to treat ESRD in patients infected with HIV Ten patients with controlled HIV infection will receive renal allografts under an immunosuppressive regimen designed to complement HAART protocols Immune system monitoring will be performed specifically to evaluate the effect of immunosuppressive drugs on the T cell function and viral burden of allograft recipients The allograft will be periodically evaluated to assess the prevalence of disease recurrence or rejection Pharmacokinetic evaluation will be performed to define the interactions between HAART and immunosuppressive drug regimens Long-term outcome will be assessed at 1 and 5 years and compared to contemporaneous outcomes for non-infected patients receiving the standard of care It is hoped that this protocol will suggest ways of providing HIV infected patients with renal replacement therapy without jeopardizing their control over their viral infection
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 |
|---|---|---|---|
| 01-DK-0061 | None | None | None |