Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001650
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Use of Bromodeoxyuridine to Study White Blood Cell Replication and Survival in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of Lymphocyte Kinetics Using Bromodeoxyuridine
Status:
COMPLETED
Status Verified Date:
2011-05-13
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 how quickly white blood cells called CD4 lymphocytes reproduce and how long they live in people infected with HIV It will do this using bromodeoxyuridine BrDU a compound that is structurally similar to thymidine one of the building blocks of DNA BrDU gets incorporated into DNA instead of thymidine but it can only get into cells that are replicating Therefore measuring the proportion of cells with BrDU indicates how many cells are replicating
HIV-infected patients 18 years of age and older may be eligible for this study Candidates will be screened with a medical history physical examination chest X-ray electrocardiogram EKG and blood tests
Participants will be given an infusion of BrDU through a catheter thin plastic tube placed in an arm vein Blood will be drawn up to 4 times in the first 24 hours after the infusion
Additional samples will then be collected as often as daily for the first week twice a week for the next 3 weeks and then weekly to monthly for up to 1 year Some patients may undergo a tissue biopsy removal of a small tissue sample from a lymph node tonsil or colon or computed tomography CT scans of the thymus a small gland between the lungs that manufactures lymphocytes Some patients will have a second infusion in order to examine changes in the rate of CD4 replication over time or following potent antiretroviral therapy Patients will be followed in the clinic periodically for the first year and then will be seen in the clinic or contacted by telephone once a year for 4 more years
The results of this study may provide a better understanding of how HIV causes disease and how therapy affects the immune system
HIV-infected patients 18 years of age and older may be eligible for this study Candidates will be screened with a medical history physical examination chest X-ray electrocardiogram EKG and blood tests
Participants will be given an infusion of BrDU through a catheter thin plastic tube placed in an arm vein Blood will be drawn up to 4 times in the first 24 hours after the infusion
Additional samples will then be collected as often as daily for the first week twice a week for the next 3 weeks and then weekly to monthly for up to 1 year Some patients may undergo a tissue biopsy removal of a small tissue sample from a lymph node tonsil or colon or computed tomography CT scans of the thymus a small gland between the lungs that manufactures lymphocytes Some patients will have a second infusion in order to examine changes in the rate of CD4 replication over time or following potent antiretroviral therapy Patients will be followed in the clinic periodically for the first year and then will be seen in the clinic or contacted by telephone once a year for 4 more years
The results of this study may provide a better understanding of how HIV causes disease and how therapy affects the immune system
Detailed Description:
Understanding the rate of lymphocyte replication and destruction in HIV infected patients as well as the effects of therapy on lymphocyte replication should lead to a better understanding of the mechanisms behind the immunodeficiency induced by HIV To examine this directly up to 85 HIV-infected patients will be enrolled in the study Patients will receive up to two 30 minute infusions at least one month apart of bromodeoxyuridine BrDU 200 mgm2 an analogue of thymidine BrDU is incorporated into DNA and can be measured using an anti-BrDU monoclonal antibody It can be measured in subpopulations of cells to determine the rate of replication of those cells All participants in this study will be reimbursed for the inconvenience and discomfort associated with study participation
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 |
|---|---|---|---|
| 97-I-0189 | None | None | None |