HIV InfectionsHYSOPENCT03920709
Analysis of the Nasal Mucosal Immune Response in HIV Infection
An observational study of HIV Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The principal objective is to define and compare the viral reservoir, mucosal immune responses and the microbiota of different HIV infection stages; viremic, aviremic (under treatment), natural elite controllers; The secondary objective is to compare the mucosal immune response and microbiota of HIV patients with the… Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood sample and Nasal swabs (right an left) samples
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 110 patients followed in Department of Internal Medicine and Clinical Immunology Bicetre Hospital APHP Chronic HIV-1 infected subjects * 50 Viremic subjects : plasma HIV RNA > 500 copies/mL, treatment-naive or treated (failing) regardless of the cause of persistent viremia * 50 Treated Aviremic subjects : < 50 copies/mL under treatment for at least 12 months * 10 Spontaneous Controllers from the ANRS CO21 CODEX Cohort or not (5 last viral loads < 400 copies /ml)
Who may be able to join
- Chronic HIV-1 infected subjects followed in Department of Internal Medicine and Clinical Immunology in Bicetre Hospital
- Healthy male or female aged between 20 and 69 (included) years
- Whatever the clinical status and the lymphocytes T CD4+
- Patients treatment-naive or under ARV treatment whatever the molecules
- 3 groups of patients, according to their HIV1 viral loads
- Virémic : viral load > 500 copies/mL, treatment-naive or treated (failing) regardless of the cause of persistent viremic
Show all 12Show fewer
- No Viremic : < 50 copies/ml under treatment at least from 12 months
- Spontaneous Controllers from the Codex Cohort (Controllers cohort from ANRS) or not with the following inclusion criteria Chronic HIV-1 infected subjects since 5 years, asymptomatic With 5 last viral loads < 400 copies /mL Whatever the lymphocytes T CD4 rates Naive of treatment except transient treatment for prevention of mother-to-child transmission
- Subject considered to be free on the day of study of an acute condition or infection that may interfere with the results of the study, based on the clinical examination performed by the investigator
- Caucasian and Sub Saharan patients -18,5 ≤ BMI ≤ 32 kg/m²
- Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for the scheduled visit at the investigational site. Ability to give their informed consent in writing
- Affiliated to the French social security or assimilated regimens
Who cannot join
- Participation in another clinical study in the last 3 months
- Travel in (sub-) tropical countries within the last 3 months
- Pregnant women
- Infectious diseases:
- Acute opportunistic or not, current or past infection, within the last 3 months as determined by the PI
- Ear temperature ≥ 38.4 ° C on the day of inclusion
Show all 32Show fewer
- Subject currently receiving or having received in the last 3 months antibiotics or nasal, intestinal or respiratory antiseptics
- Severe/chronic/recurrent pathological conditions, among them:
- Past or present diagnosed cancer, lymphoma, leukemia to the exception of: Persons with a history of cancer who are disease-free without treatment for 5 years or more
- Women who are disease free for 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen
- Cutaneous or cervical basal cell carcinoma
- Personal history of organ transplant
- Congenital or acquired immune deficiency (any confirmed or suspected immunosuppressive or immunodeficient condition, including history of HIV infection)
- Personal history of auto-immune diseases requiring or having previously required treatment (e.g. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sarcoidosis, Ankylosing Spondylitis, Autoimmune Hemolytic Anemia, Autoimmune Thrombocytopenic Purpura, Crohn's Disease, Psoriasis, Scleroderma, Wegener's Granulomatosis,Type I Diabetes, Thyroiditis,….)
- Splenectomy
- Acute or chronic, clinically significant, as determined by the investigator, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory
- Chronic renal impairment as defined by Renal Insufficiency: GFR<60 mL/min/1.73 m² (National Kidney Foundation (2002)
- History of clinically significant, as determined by the investigator, neurological disorder or seizures
- Any physical activity within 8 hours before the visit
- Any significant disorder of coagulation or treatment with warfarin derivatives (AVK or ACO)or heparin or antiplatelet medications within 2 months preceding inclusion
- Severe acute/chronic allergy
- Severe Asthma defined as asthma requiring a combination of two or more controller therapies (e.g. medium or high dose inhaled glucocorticosteroid and long-acting inhaled beta-2 agonist) or requiring oral glucocorticosteroids (GINA),
- Severe insect bite allergy with history of giant urticaria, Quincke edema or anaphylactic shock
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the inclusion. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for > 2 weeks (inhaled and topical steroids allowed)
- Chronic administration of NSAIDs, including aspirin: prolonged intake (> 2 weeks) within 6 months before study
- Receipt of blood products or immunoglobulins within 3 months prior the inclusion or planning to receive blood products or immunoglobulins during the study
- Hemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men
- Platelet count less than 120.000/mm3
- ALAT and/or ASAT > 3 times the upper limit of the norm (ULN)
- Receipt of any vaccination 3 months before the inclusion
- Alcohol abuse (more than 50 g of pure ethanol per day: for example, more than 4 x 150 mL glasses of wine, more than 4 x 250 mL glasses of beer, more than 4 x 40 mL glasses of high alcohol content drinks
- Illicit drug use or substance abuse within 3 months prior to inclusion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pr GOUJARD Cécile
Le Kremlin-Bicêtre, 94278
CECILE GOUJARD, +33 145 21 79 32, cecile.goujard@aphp.fr
KATIA BOURDIC, +33 1 45 21 63 16, katia.bourdic@aphp.fr
About this study
The principal objective is to define and compare the viral reservoir, mucosal immune responses and the microbiota of different HIV infection stages; viremic, aviremic (under treatment), natural elite controllers; The secondary objective is to compare the mucosal immune response and microbiota of HIV patients with the healthy control population of Milieu Interieur;
Read the detailed description
Although antiretroviral therapy (ART) efficiently suppresses viral replication HIV persists in CD4+ T cells in a form that is neither targeted by the immune system nor by ART, the complete eradication of replication competent HIV or the establishment of a long term remission state in infected individuals represents an outstanding challenge.
The persistence of reservoirs has been mainly linked to the survival and clonal expansion of pools of long lived infected memory CD4+ T cells and to low level viral replication in tissues where ART penetration may be incomplete. One such tissue may be mucosal surfaces which are challenging to study in human populations.
As part of the Milieu Interieur project, coordinated by Institut Pasteur, investigators have developed and validated a standardized approach for sampling the nasal mucosa. From this simple sampling procedure it is possible to analyze both the local mucosal host immune response at the proteomic and metabolomic level, and also the mucosal microbial flora.
As part of Milieu Interieur investigators have defined these diverse phenotypes for a subset of donors and are currently extending the analysis to the 1,000 healthy donors cohort that will give reference range values for the nasal mucosa.
Investigators wish to compare with relevant patient groups, in particular HIV infected individuals to see how infection, treatment, and natural host control may differentially impact the mucosal immune response and viral reservoir
- Conditions
- HIV Infections
- Being tested
- Blood sample and Nasal swabs (right an left) samples
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and Nasal swabs (right an left) samplesOther
Nasal swabs (right and left) will be performed (FLOQSwabTM)
Blood samples of 20 mL EDTA will be taken in addition to the current care report
| Study group | Role | What they receive |
|---|---|---|
| Chronic HIV-1 infected subjects : 50 Viremic subjects | plasma HIV RNA > 500 copies/mL, treatment-naive or treated (failing) regardless of the cause of persistent viremia Receives: Other: Blood sample and Nasal swabs (right an left) samples | |
| Chronic HIV-1 infected subjects : 50 Treated Aviremic subjects | < 50 copies/mL under treatment for at least 12 months Receives: Other: Blood sample and Nasal swabs (right an left) samples | |
| Chronic HIV-1 infected subjects :10 Spontaneous Controllers | from the ANRS CO21 CODEX Cohort or not (5 last viral loads < 400 copies /ml) Receives: Other: Blood sample and Nasal swabs (right an left) samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of HIV p24 levels in the supernatants of nasal mucosa
Measurement of HIV p24 levels in the supernatants of nasal mucosa in HIV-infected patients in the 3 groups
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
HIV p24 levels in the supernatants and in the pellets of the nasal mucosa in HIV-infected patients
Quantification of HIV p24 levels in the supernatants and in the pellets of the nasal mucosa
Measured: through study completion, an average of 2 years
Assessement of the microbiome in the nasal mucosa
Description of nasal mucosa microbiome diversity in the nasal mucosa of HIV-infected patients, and comparison with control subjects from the Milieu intérieur Cohort
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start2 Jun 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pasteur Institute of Paris
- Responsible party
- Sponsor
- Investigators
- Cécile Goujard, Pr, Principal investigator, AP-HP Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920709
- Sponsor's protocol ID
- HYSOPE
- Acronym
- HYSOPE
- Status last verified
- Sep 2022
- First submitted
- 10 Jan 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be entered electronically via a web browser in Electronic Case Report Form Data will be analysed by Pasteur Institute of Paris with the biological results
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Nasal Mucosal Immune Response in HIV Infection
- ClinicalTrials.gov ID
- NCT03920709
- Acronym / sponsor ID
- HYSOPE / HYSOPE
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pasteur Institute of Paris
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 19 Apr 2019 (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.
The principal objective is to define and compare the viral reservoir, mucosal immune responses and the microbiota of different HIV infection stages; viremic, aviremic (under treatment), natural elite controllers; The secondary objective is to compare the mucosal immune response and microbiota of HIV patients with the healthy control population of Milieu Interieur;
Detailed description
Although antiretroviral therapy (ART) efficiently suppresses viral replication HIV persists in CD4+ T cells in a form that is neither targeted by the immune system nor by ART, the complete eradication of replication competent HIV or the establishment of a long term remission state in infected individuals represents an outstanding challenge.
The persistence of reservoirs has been mainly linked to the survival and clonal expansion of pools of long lived infected memory CD4+ T cells and to low level viral replication in tissues where ART penetration may be incomplete. One such tissue may be mucosal surfaces which are challenging to study in human populations.
As part of the Milieu Interieur project, coordinated by Institut Pasteur, investigators have developed and validated a standardized approach for sampling the nasal mucosa. From this simple sampling procedure it is possible to analyze both the local mucosal host immune response at the proteomic and metabolomic level, and also the mucosal microbial flora.
As part of Milieu Interieur investigators have defined these diverse phenotypes for a subset of donors and are currently extending the analysis to the 1,000 healthy donors cohort that will give reference range values for the nasal mucosa.
Investigators wish to compare with relevant patient groups, in particular HIV infected individuals to see how infection, treatment, and natural host control may differentially impact the mucosal immune response and viral reservoir
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic HIV-1 infected subjects : 50 Viremic subjects | – | Other: Blood sample and Nasal swabs (right an left) samplesplasma HIV RNA > 500 copies/mL, treatment-naive or treated (failing) regardless of the cause of persistent viremia |
| Chronic HIV-1 infected subjects : 50 Treated Aviremic subjects | – | Other: Blood sample and Nasal swabs (right an left) samples< 50 copies/mL under treatment for at least 12 months |
| Chronic HIV-1 infected subjects :10 Spontaneous Controllers | – | Other: Blood sample and Nasal swabs (right an left) samplesfrom the ANRS CO21 CODEX Cohort or not (5 last viral loads < 400 copies /ml) |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 110 patients followed in Department of Internal Medicine and Clinical Immunology Bicetre Hospital APHP Chronic HIV-1 infected subjects * 50 Viremic subjects : plasma HIV RNA > 500 copies/mL, treatment-naive or treated (failing) regardless of the cause of persistent viremia * 50 Treated Aviremic subjects : < 50 copies/mL under treatment for at least 12 months * 10 Spontaneous Controllers from the ANRS CO21 CODEX Cohort or not (5 last viral loads < 400 copies /ml)
Key inclusion criteria (12 listed)
- Chronic HIV-1 infected subjects followed in Department of Internal Medicine and Clinical Immunology in Bicetre Hospital
- Healthy male or female aged between 20 and 69 (included) years
- Whatever the clinical status and the lymphocytes T CD4+
- Patients treatment-naive or under ARV treatment whatever the molecules
- 3 groups of patients, according to their HIV1 viral loads
Key exclusion criteria (32 listed)
- Participation in another clinical study in the last 3 months
- Travel in (sub-) tropical countries within the last 3 months
- Pregnant women
- Infectious diseases:
- Severe/chronic/recurrent pathological conditions, among them:
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 sample and Nasal swabs (right an left) samplesNasal swabs (right and left) will be performed (FLOQSwabTM) Blood samples of 20 mL EDTA will be taken in addition to the current care report | Other | Chronic HIV-1 infected subjects : 50 Treated Aviremic subjects, Chronic HIV-1 infected subjects : 50 Viremic subjects, Chronic HIV-1 infected subjects :10 Spontaneous Controllers |
Primary outcome
Measurement of HIV p24 levels in the supernatants of nasal mucosa
Time frame: through study completion, an average of 2 years
Measurement of HIV p24 levels in the supernatants of nasal mucosa in HIV-infected patients in the 3 groups
2 secondary outcomes
HIV p24 levels in the supernatants and in the pellets of the nasal mucosa in HIV-infected patients
Time frame: through study completion, an average of 2 years
Assessement of the microbiome in the nasal mucosa
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Yes. Data will be entered electronically via a web browser in Electronic Case Report Form Data will be analysed by Pasteur Institute of Paris with the biological results
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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. This study is not recruiting at the moment.
Cécile Goujard, Pr principal investigator
AP-HP Hôpital Bicêtre
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 Infections, run by Assistance Publique - Hôpitaux de Paris 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 12 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile Goujard, Pr (+33145217932, cecile.goujard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of HIV p24 levels in the supernatants of nasal mucosa (time frame: through study completion, an average of 2 years). 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 8 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.