HIVPLAQUAGENCT07745530
Platelets Target the Circulating HIV Reservoir: Implications for Immunological Failure
An observational study of HIV, run by Tourcoing Hospital at 1 site in France.
Trial summary
HIV/AIDS is a chronic disease that is difficult to eradicate because the virus persists as proviral DNA integrated into the host cells. Despite antiretroviral therapy, proviral DNA persists in lymphoid and myeloid reservoirs, whether circulating (memory CD4+ T cells) or tissue-based (macrophages). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- blood sampling
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to 1 Oct 2026
- 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: Adult patient living with HIV consulting in Tourcoing Hospital
Who may be able to join
- Adult patients living with HIV with an undetectable viral load for more than 2 years
- Beneficiary of a social security scheme or rightful claimant;
- Patients able to read and understand the information sheet;
- Having signed the consent form.
Who cannot join
- being unable to give free and informed consent;
- pregnant or breastfeeding woman;
- being under guardianship, curatorship, or a protection mandate;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Tourcoing
Tourcoing, 59200
Jean-Jacques Vitagliano, PhD, 0320694280, jjvitagliano@ch-tourcoing.fr
Olivier Robineau, MD, PhD
About this study
Official title: PLAQUAGE - Platelets Target the Circulating HIV Reservoir: Implications for Immunological Failure
HIV/AIDS is a chronic disease that is difficult to eradicate because the virus persists as proviral DNA integrated into the host cells. Despite antiretroviral therapy, proviral DNA persists in lymphoid and myeloid reservoirs, whether circulating (memory CD4+ T cells) or tissue-based (macrophages). HIV reservoirs are highly heterogeneous, making it difficult to identify a specific biomarker or cell profile for a given reservoir. A distinctive feature of HIV reservoirs may be the selective interaction between reservoir cells and platelets. The presence of HIV in platelets could impact disease progression, particularly by triggering the reversal of HIV latency and leading to residual viral production. The frequency of platelets containing circulating virus in the blood is approximately 0.1% of the total platelet volume. Although seemingly negligible, this would represent a daily input of 10⁸ platelets harboring the virus. Furthermore, patients whose platelets contain HIV are primarily those with persistent immunological failure, known as "immunological non-responders" (InR).
The regulation of the size (number and frequency) of the HIV reservoir by platelets is not known. However, HIV-containing platelets form more conjugates with CD4+ T cells than HIV-free platelets. While HIV-containing platelets do not productively infect cells, they induce metabolic dysfunction in CD4+ T cells (aerobic glycolysis). Increased aerobic glycolysis is a hallmark of T cell activation and senescence.
This suggests an interconnection between the presence of the virus in platelets, the size of the reservoir, and immune dysfunction in HIV.
- Conditions
- HIV
- Being tested
- blood sampling
- Keywords
- hiv, platelet
- 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 samplingOther
During a routine consultation, a specific 40 mL blood sample will be collected for the study.
| Study group | Role | What they receive |
|---|---|---|
| Immunological non-responders 1 | Immunological non-responders (<500 CD4+ T cells/µL, undetectable viral load for >2 years) with a CD4+ T cell nadir below 100. Receives: Other: blood sampling | |
| Immunological responders | Immunological responders (>500 CD4+ T cells/µL, undetectable viral load for >2 years) Receives: Other: blood sampling | |
| Immunological non-responders 2 | Immunological non-responders (<500 CD4+ T cells/µL, undetectable viral load for >2 years) with a CD4+ T cell nadir between 200 and 500 Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo evaluation of the formation of platelet-PBMC conjugates enriched in latent or active reservoirs and of their transcriptional competence
In vivo evaluation of the formation of platelet-PBMC conjugates enriched in latent or active reservoirs, correlated with immune status through the following parameters:
Frequency of CD4+ T lymphocytes associated with platelets and/or platelet components, Frequency of platelet-associated CD4+ T cells carrying HIV RNA, and ex vivo HIV reactivation; Number of integrated HIV provirus copies in CD4+ T cells associated or not with platelets.
Monitoring of the transcriptional competence of platelet-associated reservoirs ex vivo, and the capacity of platelets to reactivate these reservoirs (latency reversal) in vitro based on the following criterion:
Frequency of J-Lat GFP+ cells (indicating a reactivated provirus in this reporter cell) after coculture with platelets obtained from individuals of the different experimental groups.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Apr 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Robineau, MD, PhD, Principal investigator, Centre Hospitalier de Tourcoing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745530
- Sponsor's protocol ID
- CHT/URC/2023/10
- Acronym
- PLAQUAGE
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 17 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLAQUAGE - Platelets Target the Circulating HIV Reservoir: Implications for Immunological Failure
- ClinicalTrials.gov ID
- NCT07745530
- Acronym / sponsor ID
- PLAQUAGE / CHT/URC/2023/10
- Conditions
- HIV
- Keywords
- hiv, platelet
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 Aug 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.
HIV/AIDS is a chronic disease that is difficult to eradicate because the virus persists as proviral DNA integrated into the host cells. Despite antiretroviral therapy, proviral DNA persists in lymphoid and myeloid reservoirs, whether circulating (memory CD4+ T cells) or tissue-based (macrophages). HIV reservoirs are highly heterogeneous, making it difficult to identify a specific biomarker or cell profile for a given reservoir. A distinctive feature of HIV reservoirs may be the selective interaction between reservoir cells and platelets. The presence of HIV in platelets could impact disease progression, particularly by triggering the reversal of HIV latency and leading to residual viral production. The frequency of platelets containing circulating virus in the blood is approximately 0.1% of the total platelet volume. Although seemingly negligible, this would represent a daily input of 10⁸ platelets harboring the virus. Furthermore, patients whose platelets contain HIV are primarily those with persistent immunological failure, known as "immunological non-responders" (InR).
The regulation of the size (number and frequency) of the HIV reservoir by platelets is not known. However, HIV-containing platelets form more conjugates with CD4+ T cells than HIV-free platelets. While HIV-containing platelets do not productively infect cells, they induce metabolic dysfunction in CD4+ T cells (aerobic glycolysis). Increased aerobic glycolysis is a hallmark of T cell activation and senescence.
This suggests an interconnection between the presence of the virus in platelets, the size of the reservoir, and immune dysfunction in HIV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immunological non-responders 1 | – | Other: blood samplingImmunological non-responders (<500 CD4+ T cells/µL, undetectable viral load for >2 years) with a CD4+ T cell nadir below 100. |
| Immunological responders | – | Other: blood samplingImmunological responders (>500 CD4+ T cells/µL, undetectable viral load for >2 years) |
| Immunological non-responders 2 | – | Other: blood samplingImmunological non-responders (<500 CD4+ T cells/µL, undetectable viral load for >2 years) with a CD4+ T cell nadir between 200 and 500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient living with HIV consulting in Tourcoing Hospital
Key inclusion criteria (4 listed)
- Adult patients living with HIV with an undetectable viral load for more than 2 years
- Beneficiary of a social security scheme or rightful claimant;
- Patients able to read and understand the information sheet;
- Having signed the consent form.
Key exclusion criteria (3 listed)
- being unable to give free and informed consent;
- pregnant or breastfeeding woman;
- being under guardianship, curatorship, or a protection mandate;
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 samplingDuring a routine consultation, a specific 40 mL blood sample will be collected for the study. | Other | Immunological non-responders 1, Immunological non-responders 2, Immunological responders |
Primary outcome
In vivo evaluation of the formation of platelet-PBMC conjugates enriched in latent or active reservoirs and of their transcriptional competence
Time frame: at enrollment
In vivo evaluation of the formation of platelet-PBMC conjugates enriched in latent or active reservoirs, correlated with immune status through the following parameters: Frequency of CD4+ T lymphocytes associated with platelets and/or platelet components, Frequency of platelet-associated CD4+ T cells carrying HIV RNA, and ex vivo HIV reactivation; Number of integrated HIV provirus copies in CD4+ T cells associated or not with platelets. Monitoring of the transcriptional competence of platelet-associated reservoirs ex vivo, and the capacity of platelets to reactivate these reservoirs (latency reversal) in vitro based on the following criterion: Frequency of J-Lat GFP+ cells (indicating a reactivated provirus in this reporter cell) after coculture with platelets obtained from individuals of the different experimental groups.
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 17 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.
Olivier Robineau, MD, PhD principal investigator
Centre Hospitalier de Tourcoing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Tourcoing Hospital at 1 site in France.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jean-Jacques VITAGLIANO, PhD (+33320694280, jjvitagliano@ch-tourcoing.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vivo evaluation of the formation of platelet-PBMC conjugates enriched in latent or active reservoirs and of their transcriptional competence (time frame: at enrollment). 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 17 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.