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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/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
16/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
112
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
Other
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/ct2/show/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
Jillian.Lau@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05852301