Innate-like and NK Signatures in Chronic-Treated HIV Infection INSTINCT-HIV (INSTINCT-HIV)
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
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Florence ADER, M.D.,PhD.
- Número de telefone: +33 472071107
- E-mail: florence.ader@chu-lyon.fr
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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);
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
People living with HIV
Adult patients living with HIV who have been receiving prolonged, continuous, suppressive antiviral treatment for at least five full years. |
A 50 ml venous blood sample is taken upon the participant's enrolment |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Identifying immune profiles associated with better control of this reservoir.
Prazo: 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). |
Day 1
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Florence ADER, M.D.,PhD., Hospices Civils de Lyon
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Infecções transmitidas pelo sangue
- Doenças urogenitais
- Doenças Genitais
- Doenças do sistema imunológico
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças de Vírus Lento
- Infecções por HIV
- Síndrome da Imunodeficiência Adquirida
- Técnicas de investigação
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Testes hematológicos
Outros números de identificação do estudo
- 69HCL26_0720
- 2026-A02069-42 (Outro identificador: ID-RCB)
Informações sobre medicamentos e dispositivos, documentos de estudo
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