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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03426189




Registration number
NCT03426189
Ethics application status
Date submitted
3/12/2017
Date registered
8/02/2018

Titles & IDs
Public title
HIV Persistence in Lymph Node and Peripheral Blood
Scientific title
HIV Persistence in Lymph Node Tissue and Peripheral Blood: The Role of Immune Checkpoints
Secondary ID [1] 0 0
1646930
Universal Trial Number (UTN)
Trial acronym
HIV-PRADA
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
Treatment: Surgery - Leukapheresis
Treatment: Surgery - Lymph node biopsy

HIV infected individuals on long term ART - * Leukapheresis
* Lymph node biopsy


Treatment: Surgery: Leukapheresis
Blood will be taken by a needle inserted into a vein in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out of the machine for purposes of this research. The rest of the blood will be returned through a needle in the other arm.

Treatment: Surgery: Lymph node biopsy
Ultrasound will be used to localize the position of one lymph node in the groin. Under a light general anesthetic, one lymph node will be removed.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of HIV-1 in cells expressing CTLA4 and PD-1 in lymph node derived cells
Timepoint [1] 0 0
Baseline only
Secondary outcome [1] 0 0
Frequency of HIV-1 in cells expressing CTLA4 and PD-1 in blood derived cells
Timepoint [1] 0 0
Baseline only
Secondary outcome [2] 0 0
Change in interferon gamma production in HIV specific T-cells following ex vivo blockade of PD-1 and CTLA4
Timepoint [2] 0 0
Baseline only

Eligibility
Key inclusion criteria
* Written Informed Consent
* Willing to undergo leukapheresis and lymph node biopsy
* Documented HIV-1 infection (antibody positive or detectable plasma HIV-1 RNA)
* Receiving combination ART
* HIV RNA < 50 copies/mL for > 3 years (Episodes of a single HIV plasma RNA 50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was <50 copies/mL)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unwillingness to follow protocol requirements
* Contraindications to LN biopsy or leukapheresis
* Current skin infection of inguinal area
* Known current lower extremity, gastrointestinal or genitourinary infection

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2018
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
amfAR, The Foundation for AIDS Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of California, San Francisco
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Université de Montréal
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The Avenue Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Oregon Health and Science University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Johns Hopkins University
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Lewin
Address 0 0
The Peter Doherty Institute for Infection and Immunity, University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT03426189