Analysis of the Nasal Mucosal Immune Response in HIV Infection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Measurement of HIV p24 levels in the supernatants of nasal mucosa
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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;
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Assessement of the microbiome in the nasal mucosa(through study completion, an average of 2 years)
- 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)