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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

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]

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

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

HIV-DNA

Timepoint [1]

at baseline

Secondary outcome [1]

Reservoir measurements

Timepoint [1]

at baseline

Secondary outcome [2]

Reservoir measurements

Timepoint [2]

at baseline

Secondary outcome [3]

Reservoir measurements

Timepoint [3]

at baseline

Secondary outcome [4]

HIV-specific T-cell responses

Timepoint [4]

at baseline

Secondary outcome [5]

Decay of reservoir

Timepoint [5]

at 12 months

Secondary outcome [6]

Decay of reservoir

Timepoint [6]

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]

Alfred Health - Prahran

Recruitment postcode(s) [1]

3181 - Prahran

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Other collaborator category [1]

Other

Name [1]

The Peter Doherty Institute for Infection and Immunity

Address [1]

Country [1]

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

Jillian Lau, MBBS

Address

The Alfred

Country

Phone

Fax

Contact person for public queries

Name

Jillian Lau, MBBS

Address

Country

Phone

613 90766908

Fax

[email protected]

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/NCT05852301

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