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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02732457
Registration number
NCT02732457
Ethics application status
Date submitted
23/03/2016
Date registered
8/04/2016
Date last updated
8/11/2021
Titles & IDs
Public title
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
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Scientific title
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
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Secondary ID [1]
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IVPPHSCT01
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Universal Trial Number (UTN)
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Trial acronym
HSCT-HIV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR
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Assessment method [1]
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HIV-1 DNA in CD4+ T cells will be measured by real-time PCR and reported as HIV-1 DNA copies in 10e6 CD4+ T cells
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot
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Assessment method [1]
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HIV-1 antigens and antibodies (Ag/Ab) in peripheral blood will be measured by 4th generation chemiluminescence microparticle immunoassay (CMIA) and by Western blot (WB).
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Timepoint [1]
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3 years
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Eligibility
Key inclusion criteria
- HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their
treating Physician (Haematologist).
- Over 18 years of age
- Provision of written, informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- In the opinion of the investigator that the patient is not able to provide informed
consent
- Hb < 9 (g/dL)
- CD4+ T cell count <100 (cells/µl)
- Serious coagulation abnormalities, platelet count < 50.
- Patients currently taking medications that significantly affect the bleeding time
(e.g. warfarine, clexane, FXa antagonists)
- History of allergy to local anaesthetics
- Pregnancy
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2015
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell
transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune
response.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02732457
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mark Polizzotto, MD
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Address
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St Vincent's Hospital, Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02732457
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