HIV InfectionNCT00001243
Effects of HIV on the Development and Function of Bone Marrow Cells
An observational study of HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1989to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: Effects of Infection With the Human Immunodeficiency Virus on the Development and Function of Bone Marrow Cells
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.
Read more
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.
Read the 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 (e.g., 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 Balb/c 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.
- Conditions
- HIV Infection
- Keywords
- AIDS, Myeloid Progenitors, Monocytes, Plasmid Libraries, Cytokines
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startFeb 1989
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001243
- Sponsor's protocol ID
- 890035
- Other IDs
- 89-I-0035
- Status last verified
- Dec 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 2460922Donahue 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.
PubMed 2434864Steinberg 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.
PubMed 2002542
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infection With the Human Immunodeficiency Virus on the Development and Function of Bone Marrow Cells
- ClinicalTrials.gov ID
- NCT00001243
- Acronym / sponsor ID
- 890035
- Conditions
- HIV Infection
- Keywords
- AIDS, Myeloid Progenitors, Monocytes, Plasmid Libraries, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 1989
- Study completion
- Dec 2005
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (e.g., 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 Balb/c 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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 2460922Folks 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.
- Background: PubMed 2434864Donahue 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.
- Background: PubMed 2002542Steinberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001243, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.