| Registry | NCT07849933, acronym INSTINCT-HIV |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Hospices Civils de Lyon (Other) |
| Conditions | Human Immunodeficiency Virus Infection (HIV) |
| Interventions | Blood test (Biological) |
| Dates | start 2027-01-12 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-09-30, last updated 2026-09-30 |
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All trials for Human Immunodeficiency Virus Infection (HIV) All trials of Blood test
Infection with the human immunodeficiency virus (HIV) is a chronic condition requiring lifelong antiretroviral therapy (ART). Despite prolonged virological control under suppressive ART, HIV persists in the form of a stable viral reservoir known as the 'integrated' reservoir, mainly localised in CD4+ memory T cells, which constitutes the obstacle to a functional or sterilising cure of the infection. The immunological mechanisms involved in the control, stability or gradual depletion of this reservoir are still not fully understood.
Among the cellular populations of the innate immune system, Natural Killer (NK) cells play an important role in the trajectory of the reservoir by having the ability to eliminate HIV-infected cells. However, several studies have shown that these NK cells exhibit variable capabilities in eliminating such cells, suggesting that inter-individual heterogeneity in innate immune responses may contribute to the observed differences in the size and persistence of the viral reservoir in people living with HIV (PLHIV) on long-term suppressive ART. Functionally, interactions between NK cell receptors and class I HLA molecules (HLA I) strongly modulate the education, repertoire and effector functions of NK cells, indicating that the immunogenetics of the host's HLA I alleles is therefore a major determinant of this variability. Certain receptor/HLA I combinations, notably receptors known as KIRs, have been associated with differences in the progression of HIV infection and immunovirological control. Consequently, their role in the dynamics of the viral reservoir during prolonged suppressive ART needs to be explored. Finally, biological sex significantly influences anti-HIV immune responses, with females showing a favourable response. Whilst sex differences in NK cell function and immune activation have been described, the impact of biological sex on the dynamics of the HIV reservoir under prolonged suppressive ART remains largely unknown and requires further investigation
| Arm | Type | Interventions | Description |
|---|---|---|---|
| People living with HIV | Biological: Blood test | Adult patients living with HIV who have been receiving prolonged, continuous, suppressive antiviral treatment for at least five full years. |
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Be aged 18 or over;
* Be living with HIV-1 infection;
* Be under the care of the Department of Infectious and Tropical Diseases at the Lyon university Hopsital (Hospices Civils de Lyon);
* Have been receiving continuous ART for at least 5 full years;
* Have a consistently undetectable plasma HIV viral load whilst on ART;
* Have experienced no more than two isolated episodes of virological rebound ('blips') ≥ 100 copies/mL;
* Have usable biological samples for the planned analyses and/or agree to the collection of samples required for the research;
* Have received written and verbal information about the research;
* Have signed the written consent form prior to any research-specific procedures.
Exclusion Criteria:
* Patients who have taken part in an interventional therapeutic trial specifically targeting an HIV cure strategy likely to have a lasting effect on the immunological or virological parameters under investigation;
* Patients who have experienced more than two episodes of virological rebound ≥ 100 copies/mL whilst on ART;
* Pregnant women, women in labour or breastfeeding women;
* Persons deprived of their liberty by judicial or administrative order;
* Persons subject to a legal protection order;
* Adults subject to a legal protection measure (guardianship, curatorship);
* Persons admitted to a health or social care facility for purposes other than research;
* Persons receiving psychiatric care;
* Persons who have expressed their objection to participating in the research or to the use of their data and biological samples.