Blood DiseaseNCT00006314
Cytomegalovirus Spread and Reactivation in Blood Cells
An observational study of Blood Disease and Cytomegalovirus Infections, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the relationship between HCMV and bone marrow progenitor cells to understand whether HCMV is latent in CD34 + bone marrow progenitors and the mechanism by which the virus remains in a latent state. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Blood Disease, Cytomegalovirus Infections
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1999to Jun 2004
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the relationship between HCMV and bone marrow progenitor cells to understand whether HCMV is latent in CD34 + bone marrow progenitors and the mechanism by which the virus remains in a latent state.
Read the detailed description
BACKGROUND:
Despite progress in understanding the pathophysiology of human cytomegalovirus (HCMV) infections, its manifestations in the immune compromised host are frequently associated with high morbidity and mortality. In this setting, HCMV disease can develop e.g. following immune suppression as a result of reactivation of latent HCMV acquired earlier in life. The mechanisms leading to establishment of latent infections and their subsequent reactivation are not clear. It is also unknown whether HCMV exists in a latent form with limited viral gene expression or as a persistent infection with normal virus transcription.
DESIGN NARRATIVE:
The specific aims of the study were to: 1) examine the percentage of HCMV positive donors whose bone marrow progenitors contained HCMV DNA using nested PCR and determine if virus could be rescued from those cells. 2) Analyze the HCMV life cycle in hematopoietic progenitor and stem cells. 3) identify and analyze HCMV gene expression in in vivo infected leukocytes. Bone marrow progenitors containing HCMV DNA detectable by nested PCR were isolated from human donors and used as as source of mRNA to prepare Cdna libraries. 4) Determine if gene(s) expressed in bone marrow progenitors were important in either establishing or maintaining a latent infection or in the lytic cycle of HCMV. Information provided from the above studies yielded information important in planning future approaches for the therapy of HCMV infections.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Blood Disease, Cytomegalovirus Infections
- Medical subject headings
- Hematologic Diseases, Cytomegalovirus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2000 (estimated)
- Study startJul 1999
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen St. Jeor, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006314
- Sponsor's protocol ID
- 922
- Other IDs
- R01HL063470
- Status last verified
- Jan 2006
- First submitted
- 28 Sep 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Crapnell K, Zanjani ED, Chaudhuri A, Ascensao JL, St Jeor S, Maciejewski JP. In vitro infection of megakaryocytes and their precursors by human cytomegalovirus. Blood. 2000 Jan 15;95(2):487-93.
PubMed 10627453Rizvanov AA, van Geelen AG, Morzunov S, Otteson EW, Bohlman C, Pari GS, St Jeor SC. Generation of a recombinant cytomegalovirus for expression of a hantavirus glycoprotein. J Virol. 2003 Nov;77(22):12203-10. doi: 10.1128/jvi.77.22.12203-12210.2003.
PubMed 14581557Khaiboullina SF, Maciejewski JP, Crapnell K, Spallone PA, Dean Stock A, Pari GS, Zanjani ED, Jeor SS. Human cytomegalovirus persists in myeloid progenitors and is passed to the myeloid progeny in a latent form. Br J Haematol. 2004 Aug;126(3):410-7. doi: 10.1111/j.1365-2141.2004.05056.x.
PubMed 15257715Bego M, Maciejewski J, Khaiboullina S, Pari G, St Jeor S. Characterization of an antisense transcript spanning the UL81-82 locus of human cytomegalovirus. J Virol. 2005 Sep;79(17):11022-34. doi: 10.1128/JVI.79.17.11022-11034.2005.
PubMed 16103153
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus Spread and Reactivation in Blood Cells
- ClinicalTrials.gov ID
- NCT00006314
- Acronym / sponsor ID
- 922
- Conditions
- Blood Disease, Cytomegalovirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1999
- Study completion
- Jun 2004 (actual)
- First posted
- 29 Sep 2000 (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.
To investigate the relationship between HCMV and bone marrow progenitor cells to understand whether HCMV is latent in CD34 + bone marrow progenitors and the mechanism by which the virus remains in a latent state.
Detailed description
BACKGROUND:
Despite progress in understanding the pathophysiology of human cytomegalovirus (HCMV) infections, its manifestations in the immune compromised host are frequently associated with high morbidity and mortality. In this setting, HCMV disease can develop e.g. following immune suppression as a result of reactivation of latent HCMV acquired earlier in life. The mechanisms leading to establishment of latent infections and their subsequent reactivation are not clear. It is also unknown whether HCMV exists in a latent form with limited viral gene expression or as a persistent infection with normal virus transcription.
DESIGN NARRATIVE:
The specific aims of the study were to: 1) examine the percentage of HCMV positive donors whose bone marrow progenitors contained HCMV DNA using nested PCR and determine if virus could be rescued from those cells. 2) Analyze the HCMV life cycle in hematopoietic progenitor and stem cells. 3) identify and analyze HCMV gene expression in in vivo infected leukocytes. Bone marrow progenitors containing HCMV DNA detectable by nested PCR were isolated from human donors and used as as source of mRNA to prepare Cdna libraries. 4) Determine if gene(s) expressed in bone marrow progenitors were important in either establishing or maintaining a latent infection or in the lytic cycle of HCMV. Information provided from the above studies yielded information important in planning future approaches for the therapy of HCMV infections.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 13 May 2016.
- Background: PubMed 10627453Crapnell K, Zanjani ED, Chaudhuri A, Ascensao JL, St Jeor S, Maciejewski JP. In vitro infection of megakaryocytes and their precursors by human cytomegalovirus. Blood. 2000 Jan 15;95(2):487-93.
- Background: PubMed 14581557Rizvanov AA, van Geelen AG, Morzunov S, Otteson EW, Bohlman C, Pari GS, St Jeor SC. Generation of a recombinant cytomegalovirus for expression of a hantavirus glycoprotein. J Virol. 2003 Nov;77(22):12203-10. doi: 10.1128/jvi.77.22.12203-12210.2003.
- Background: PubMed 15257715Khaiboullina SF, Maciejewski JP, Crapnell K, Spallone PA, Dean Stock A, Pari GS, Zanjani ED, Jeor SS. Human cytomegalovirus persists in myeloid progenitors and is passed to the myeloid progeny in a latent form. Br J Haematol. 2004 Aug;126(3):410-7. doi: 10.1111/j.1365-2141.2004.05056.x.
- Background: PubMed 16103153Bego M, Maciejewski J, Khaiboullina S, Pari G, St Jeor S. Characterization of an antisense transcript spanning the UL81-82 locus of human cytomegalovirus. J Virol. 2005 Sep;79(17):11022-34. doi: 10.1128/JVI.79.17.11022-11034.2005.
Related trials for Blood Disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
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.
Stephen St. Jeor
University of Nevada, Las Vegas
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease and Cytomegalovirus Infections, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 NCT00006314, which also lists 4 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 13 May 2016.