Analysis of the Nasal Mucosal Immune Response in HIV Infection

NCT03920709 | Unknown DMC

• 1 other identifier: HYSOPE
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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 healthy control population of Milieu Interieur;

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

  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

  through study completion, an average of 2 years

• Assessement of the microbiome in the nasal mucosa

  through study completion, an average of 2 years

Study Arms (3)

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

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

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)

Other: Blood sample and Nasal swabs (right an left) samples

Interventions

Blood sample and Nasal swabs (right an left) samples OTHER

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

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

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• 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
• 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
• No Viremic : \< 50 copies/ml under treatment at least from 12 months
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Pasteur Institute of Paris: collaborator

Study Sites (1)

Pr GOUJARD Cécile

Le Kremlin-Bicêtre, 94278, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample and nasal mucosa

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Cécile Goujard, Pr

  AP-HP Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Goujard, Pr

CONTACT

+33145217932; cecile.goujard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: April 19, 2019
• Study Start: June 2, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: At the end of the study
• Access Criteria: The persons responsible for the quality control of clinical studies (the French Public Health Code) will take all necessary precautions to ensure the confidentiality of information relating to the research, the participants and in particular their identity and the results obtained. These persons, as well as the investigators themselves, are bound by professional secrecy. During and after the research, all data collected about the participants and sent to the Pasteur Institute of Paris by the investigators will be anonymized. Under no circumstances will the names and addresses of the participants be shown. The sponsor will ensure that each participant has agreed in writing for any personal information about him or her which is strictly necessary for the quality control of the study to be accessed Identification of the person responsible and the location for data processing. Statistical analysis will be performed by scientist and IPP bio-informatician within the research units involved.

Locations

FR (1)