Effects of HIV on the Development and Function of Bone Marrow Cells
Effects of Infection With the Human Immunodeficiency Virus on the Development and Function of Bone Marrow Cells
2 other identifiers
observational
300
1 country
1
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 1/2-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 1989
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1989
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMarch 4, 2008
December 1, 2005
November 3, 1999
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Both HIV seropositive and seronegative individuals.
- Have adequate blood counts (HIV positive volunteers: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 50,000; HIV negative healthy normal volunteers: hemoglobin greater than or equal to 12.5 g/dL, HCT greater than or equal to 38%, platelets greater than or equal to 150,000.
- Aged 18 years or older, male or female.
- Ability to give informed, written consent.
You may not qualify if:
- Women who are pregnant.
- Patients/volunteers with blood clotting disorders as demonstrated by an elevated PT, PTT or low platelet count (Seropositive: platelets greater than or equal to 50,000; Seronegative: platelets greater than or equal to150,000.
- Patients/Volunteers who are taking NSAIDS or other anti-coagulant medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Folks TM, Kessler SW, Orenstein JM, Justement JS, Jaffe ES, Fauci AS. Infection and replication of HIV-1 in purified progenitor cells of normal human bone marrow. Science. 1988 Nov 11;242(4880):919-22. doi: 10.1126/science.2460922.
PMID: 2460922BACKGROUNDDonahue RE, Johnson MM, Zon LI, Clark SC, Groopman JE. Suppression of in vitro haematopoiesis following human immunodeficiency virus infection. Nature. 1987 Mar 12-18;326(6109):200-3. doi: 10.1038/326200a0.
PMID: 2434864BACKGROUNDSteinberg HN, Crumpacker CS, Chatis PA. In vitro suppression of normal human bone marrow progenitor cells by human immunodeficiency virus. J Virol. 1991 Apr;65(4):1765-9. doi: 10.1128/JVI.65.4.1765-1769.1991.
PMID: 2002542BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
February 1, 1989
Study Completion
December 1, 2005
Last Updated
March 4, 2008
Record last verified: 2005-12