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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02732457




Registration number
NCT02732457
Ethics application status
Date submitted
23/03/2016
Date registered
8/04/2016

Titles & IDs
Public title
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
Scientific title
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
Secondary ID [1] 0 0
IVPPHSCT01
Universal Trial Number (UTN)
Trial acronym
HSCT-HIV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR
Assessment method [1] 0 0
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
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
3 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Mark Polizzotto, MD
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02732457