Optimizing cohorts for HIV cure interventions

Optimising Cohorts for HIV Cure Interventions: the Role of Very High CD4 T Cell Counts: HI-ART Study

This study is trying to find out if people with high CD4 T cell counts before starting HIV treatment respond better to potential HIV cure options by looking at their immune responses and the amount of HIV in their bodies.

Quick facts

• Study type: Observational
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bayside Health (other gov)
• Locations: 1 site (Prahran, Victoria)
• Trial ID: NCT05852301 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a prospective cohort of individuals with high CD4 T cell counts prior to starting antiretroviral therapy (ART) and those who achieve very high CD4 counts shortly after initiation. It will characterize the HIV reservoir and immune responses in these individuals and compare them to age-matched controls with lower CD4 counts. The study seeks to identify those who may respond best to HIV cure interventions by measuring the frequency of cells containing HIV DNA and assessing immune responses. The research is conducted at Alfred Health and its clinical partners.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 18 years or older with documented HIV infection who have been on continuous ART for at least two years and have high CD4 T cell counts.

Not a fit: Patients who are HIV negative or do not meet the criteria for high CD4 counts will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved identification of patients who may benefit from HIV cure interventions, potentially reducing the need for lifelong ART.

How similar studies have performed: Previous studies have shown that smaller HIV reservoirs are associated with better outcomes, indicating that this approach has potential based on prior findings.

Eligibility criteria

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;

Exclusion Criteria:

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

Where this trial is running

Prahran, Victoria

• Alfred Health — Prahran, Victoria, Australia (RECRUITING)

Study contacts

• Principal investigator: Jillian Lau, MBBS — The Alfred
• Study coordinator: Jillian Lau, MBBS

Conditions: HIV-1-infection