Optimising Cohorts for HIV Cure Interventions

NCT05852301 | Unknown

• 1 other identifier: 413.22
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• HIV-DNA

  Quantitative DNA measurements in CD4+ T cells by PCR

  at baseline

Secondary Outcomes (6)

• Reservoir measurements

  at baseline

• Reservoir measurements

  at baseline

• Reservoir measurements

  at baseline

• HIV-specific T-cell responses

  at baseline

• Decay of reservoir

  at 12 months

Study Arms (4)

HI-ART

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

Other: no intervention

HI-ART control

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

Other: no intervention

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

Other: no intervention

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: no intervention

Interventions

no intervention OTHER

no intervention, observational study only

HI-ART; HI-ART control; Hyper; Hyper control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals who are HIV antibody positive; have very high CD4 counts on ART initiation (\>800 cells/uL , known as HI-ARTs), or reconstitute their CD4 counts to \>1000 cells/μL within 48 months of commencing ART (Hypers) will be eligible for inclusion. The study will recruit people with HIV into 4 cohorts based on CD4+ T cell criteria. * CD4+ T cells \> 800 c/uL on ART initiation (HI-ARTs) * CD4+ T cells between 350-800 c/uL on ART initiation (HI-ART controls) * CD4+ T cells \<800 c/μL on ART initiation, but increase to \>1000c/μL within 48 months of ART initiation (Hypers) * CD4+ T cells reconstituted to 500-1000c/μL within 48 months (Hyper controls) The study consists of three study visits over 24 months with study visits and blood sampling at months 0, 12 and 24.

You may qualify if:

• 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;

You may not qualify if:

• Unwillingness to follow protocol requirements;
• HIV negative;
• Not meeting study definition for HI-ART or Hyper (except for control group);
• Medicare ineligible

Sponsors & Collaborators

• Bayside Health: lead
• The Peter Doherty Institute for Infection and Immunity: collaborator

Study Sites (1)

Alfred Health

Prahran, Victoria, 3181, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells

Study Officials

• Jillian Lau, MBBS

  The Alfred

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Lau, MBBS

CONTACT

613 90766908; Jillian.Lau@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 10, 2023
• Study Start: March 16, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-04

Locations

AU (1)