Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001243
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effects of HIV on the Development and Function of Bone Marrow Cells
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Infection With the Human Immunodeficiency Virus on the Development and Function of Bone Marrow Cells
Status:
COMPLETED
Status Verified Date:
2005-12
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 effects of HIV on bone marrow cells Various types of cells from bone marrow will be studied to learn which cells become infected with HIV what changes occur in the number of or growth patterns of the cells what kinds of proteins the cells make in the presence or absence of HIV and whether the cells can function normally
HIV-infected and non-infected individuals 18 years of age and older may participate in this study
Participants will undergo the following procedures
Blood draw Blood will be drawn through a needle from a hand or arm vein About 150 milliliters 10 tablespoons will be collected each time No more than 450 ml 30 tablespoons will be taken over a 6-week period
Bone marrow aspirate Bone marrow will be drawn from the hipbone For this procedure a local anesthetic is injected in the skin over the hipbone A small needle is put about 12-inch through the shell of the bone and about 3 to 4 teaspoons of marrow are drawn from the cavity into a syringe
White cells from marrow of uninfected individuals may be infected with HIV in the laboratory and grown over time for study Alternatively uninfected cells may be used as controls to compare with cells from HIV-infected individuals
White cells from marrow of HIV-infected individuals will be grown in the laboratory and studied in comparison with cells from uninfected individuals Or bone marrow cells may be injected into immune-deficient mice to try to develop an animal model for HIV infection White blood cells will also be studied in the laboratory to learn how the immune system responds to HIV infection
HIV-infected and non-infected individuals 18 years of age and older may participate in this study
Participants will undergo the following procedures
Blood draw Blood will be drawn through a needle from a hand or arm vein About 150 milliliters 10 tablespoons will be collected each time No more than 450 ml 30 tablespoons will be taken over a 6-week period
Bone marrow aspirate Bone marrow will be drawn from the hipbone For this procedure a local anesthetic is injected in the skin over the hipbone A small needle is put about 12-inch through the shell of the bone and about 3 to 4 teaspoons of marrow are drawn from the cavity into a syringe
White cells from marrow of uninfected individuals may be infected with HIV in the laboratory and grown over time for study Alternatively uninfected cells may be used as controls to compare with cells from HIV-infected individuals
White cells from marrow of HIV-infected individuals will be grown in the laboratory and studied in comparison with cells from uninfected individuals Or bone marrow cells may be injected into immune-deficient mice to try to develop an animal model for HIV infection White blood cells will also be studied in the laboratory to learn how the immune system responds to HIV infection
Detailed Description:
Hematologic abnormalities occur with high frequency up to 70 of patients in human immunodeficiency virus HIV infected individuals The pathogenesis of these abnormalities is not currently understood although both an abnormal bone marrow environment eg altered growth factor production and direct infection and dysfunction of progenitor cells themselves have been postulated Under the current protocol we have studied bone marrow precursor cells from both HIV infected and uninfected individuals and have shown not only that these cells are infectable in vitro with HIV but also infected in vivo in a subpopulation of seropositive individuals While the effects of HIV infection of precursor cells on subsequent hematopoietic potential is not completely understood we could not show a clear correlation between in vivo infection of these cells and suppressed hematopoiesis It seems clear from this study and others that other alterations within the bone marrow environment must play a role in the clinically observed hematologic abnormalities We therefore wish to continue our studies to elucidate the relative contributions of direct infection of myeloid progenitor cells and alterations in bone marrow environment in the pathology seen in HIV infected individuals Understanding the pathogenesis of abnormal hematopoiesis in HIV infection will allow investigators to design appropriate therapeutic strategies Using recently developed techniques we also wish to use bone marrow cells from HIV infected individuals to establish antibody libraries This will allow the study of immunologically important epitopes on the HIV virion with potential impact on the subsequent design of HIV vaccines or introduction of passive immunotherapy Thirdly research in the field of HIV has been hampered by the lack of an appropriate animal model One promising approach is the use of human bone marrow to reconstitute lethally irradiated Balbc mice Once the human hematopoietic system is established in the mouse it may be possible to infect these animals with HIV and study in an in vivo model the effects of infection on hematopoiesis
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 |
|---|---|---|---|
| 89-I-0035 | None | None | None |