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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05852301




Registration number
NCT05852301
Ethics application status
Date submitted
17/04/2023
Date registered
10/05/2023
Date last updated
10/05/2023

Titles & IDs
Public title
Optimising Cohorts for HIV Cure Interventions
Scientific title
Optimising Cohorts for HIV Cure Interventions: the Role of Very High CD4 T Cell Counts: HI-ART Study
Secondary ID [1] 0 0
413.22
Universal Trial Number (UTN)
Trial acronym
HI-ART
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
Other interventions - no intervention

HI-ART - People living with HIV with CD4+ T cells \> 800 c/uL on ART initiation

HI-ART control - People living with HIV with CD4+ T cells between 500-800 c/uL on ART initiation

Hyper - People living with HIV with CD4+ T cells \>800 c/µL on ART initiation, but increase to \>1000c/µL within 48 months of ART initiation

Hyper control - People living with HIV with CD4+ T cells \<500 c/µL on ART initiation and reconstituted to 500-1000c/µL within 48 months of ART initiation


Other interventions: no intervention
no intervention, observational study only

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HIV-DNA
Timepoint [1] 0 0
at baseline
Secondary outcome [1] 0 0
Reservoir measurements
Timepoint [1] 0 0
at baseline
Secondary outcome [2] 0 0
Reservoir measurements
Timepoint [2] 0 0
at baseline
Secondary outcome [3] 0 0
Reservoir measurements
Timepoint [3] 0 0
at baseline
Secondary outcome [4] 0 0
HIV-specific T-cell responses
Timepoint [4] 0 0
at baseline
Secondary outcome [5] 0 0
Decay of reservoir
Timepoint [5] 0 0
at 12 months
Secondary outcome [6] 0 0
Decay of reservoir
Timepoint [6] 0 0
at 24 months

Eligibility
Key inclusion criteria
* Aged 18 years or older
* Able to give written informed consent;
* Documented HIV infection (antibody positive);
* Taking continuous ART for at least 2 years prior to study enrolment;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unwillingness to follow protocol requirements;
* HIV negative;
* Not meeting study definition for HI-ART or Hyper (except for control group);
* Medicare ineligible

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Peter Doherty Institute for Infection and Immunity
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In a recent international substudy of START (Study of Initiation of ART in Early HIV Infection), we found that people with HIV (PHIV) who initiate ART with CD4+ T cells \> 800 cells/µL achieve a substantially smaller HIV reservoir on ART, as measured by the frequency of CD4+ T cells containing HIV DNA, compared to individuals who commence ART with CD4 counts between 500-599 and 600-799 cells/µL. We have termed these individuals 'HI-ARTs' (very High CD4 prior to ART).

Smaller reservoirs have also been noted in PHIV who achieve a CD4 count greater than 1000 cells/µL within 48 months of initiation of ART who are referred to as 'Hypers'.

This study will establish a prospective cohort of HI-ARTs and Hypers at Alfred Health and our clinical partners. It will characterise the HIV reservoir and HIV-specific immune responses in these individuals and compare these to age-matched HIV positive controls from the Alfred HIV clinic, who have CD4+ T cells between 500-800 cells/uL, or who do not reconstitute their CD4+ T cells to greater than 1000 cells/uL within 48 months.

Participants will be asked to donate a blood sample at baseline, and pending initial analyses, again at month 12 and 24.
Trial website
https://clinicaltrials.gov/study/NCT05852301
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jillian Lau, MBBS
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jillian Lau, MBBS
Address 0 0
Country 0 0
Phone 0 0
613 90766908
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05852301