Human Immunodeficiency Virus Infection (HIV)INSTINCT-HIVNCT07849933
Innate-like and NK Signatures in Chronic-Treated HIV Infection INSTINCT-HIV
An observational study of Human Immunodeficiency Virus Infection (HIV), run by Hospices Civils de Lyon.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Infection (HIV)
- What is being tested?
- Blood test
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2027to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population consists of adults aged 18 years or over living with HIV who are being monitored by the Department of Infectious and Tropical Diseases at the Hospices Civils de Lyon and who have been receiving prolonged, continuous, suppressive antiviral treatment for at least five full years. Participants must meet the following criteria: * a plasma viral load that has been consistently undetectable since the start of ART and for more than 5 years; * must not have experienced, since the start of antiviral treatment, more than two isolated episodes of virological rebound ('blips') ≥ 100 copies/mL, measured in a peripheral blood sample taken during a routine consultation.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Blood test
- Keywords
- Human Immunodeficiency Virus Infection (HIV), Antiretroviral therapy, Viral reservoir, NK cells
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
A 50 ml venous blood sample is taken upon the participant's enrolment
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV | Adult patients living with HIV who have been receiving prolonged, continuous, suppressive antiviral treatment for at least five full years. Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying immune profiles associated with better control of this reservoir.
The primary endpoint is a composite measure combining the phenotypic and functional characterisation of NK cells and related cells of the innate immune system, and the number of mononuclear cells infected with HIV provirus (reservoir).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start12 Jan 2027 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus Infection (HIV)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence ADER, M.D.,PhD., Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849933
- Sponsor's protocol ID
- 69HCL26_0720
- Other IDs
- 2026-A02069-42
- Acronym
- INSTINCT-HIV
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate-like and NK Signatures in Chronic-Treated HIV Infection INSTINCT-HIV
- ClinicalTrials.gov ID
- NCT07849933
- Acronym / sponsor ID
- INSTINCT-HIV / 69HCL26_0720
- Keywords
- Human Immunodeficiency Virus Infection (HIV), Antiretroviral therapy, Viral reservoir, NK cells
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Jan 2027 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People living with HIV | – | Biological: Blood testAdult patients living with HIV who have been receiving prolonged, continuous, suppressive antiviral treatment for at least five full years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of adults aged 18 years or over living with HIV who are being monitored by the Department of Infectious and Tropical Diseases at the Hospices Civils de Lyon and who have been receiving prolonged, continuous, suppressive antiviral treatment for at least five full years. Participants must meet the following criteria: * a plasma viral load that has been consistently undetectable since the start of ART and for more than 5 years; * must not have experienced, since the start of antiviral treatment, more than two isolated episodes of virological rebound ('blips') ≥ 100 copies/mL, measured in a peripheral blood sample taken during a routine consultation.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testA 50 ml venous blood sample is taken upon the participant's enrolment | Biological | People living with HIV |
Primary outcome
Identifying immune profiles associated with better control of this reservoir.
Time frame: Day 1
The primary endpoint is a composite measure combining the phenotypic and functional characterisation of NK cells and related cells of the innate immune system, and the number of mononuclear cells infected with HIV provirus (reservoir).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florence ADER, M.D.,PhD. principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection (HIV), run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence ADER, M.D.,PhD. (472071107 ext. +33, florence.ader@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying immune profiles associated with better control of this reservoir. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.