Effects of HIV on the Development and Function of Bone Marrow Cells
Completed
Conditions studied: HIV Infection
In brief
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.
Key facts
- Study ID
- NCT00001243
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 300
- Starts
- 1989-02-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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.
- This protocol was amended in 1990 to allow inclusion of Zairian patients who were studied by the principal investigator on site in Zaire. These marrow aspirations were all performed in March-April 1990 before the current requirements for Multi-site Collaborations were instituted. At this time, no further off-site collaboration will be undertaken under this protocol.
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.
Where it is running
- National Institute of Allergy and Infectious Diseases (NIAID) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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