- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03191175
Inflammasome Activation Via Circulating Metabolites (InflammoVIH)
Residual Immune Activation in HIV-infected Patients on Successful cART: Association Between Inflammasome Activation in Monocytes by Circulating Metabolites and Non AIDS Defining Comorbidities
The clinical challenges confronting patients with HIV has shifted over the past 10 years from acquired immunodeficiency syndrome to chronic diseases including atherosclerosis, neurocognitive disorders, and osteoporosis. Chronic low grade inflammation and monocyte activation have been consistently associated with comorbidities in HIV patients. Indeed, recent studies indicate that inflammatory mediators including IL-6, IL-1, sCD14 and s CD163 produced by monocytes, but not T-cell activation, predict Non-AIDS-related events in virologically suppressed HIV-infected persons treated with combined antiretroviral therapy (cART), highlighting the important role of monocyte activation in the occurrence of comorbidities in cART-treated HIV infected patients. Yet, the underlying molecular pathways of persistent monocyte activation in cART treated HIV-infected patients remains incompletely characterized. Our preliminary results: 1/ establish a link between the activation of the inflammasome, the increased of pyrimidine-derived metabolites and the cardiovascular risk in a cohort of elderly patients; 2/ show that treated HIV-patients are characterized by increased soluble IL-1b or IL-18 in their blood suggesting that the inflammasome pathway is activated.
Objectives: In this study we will characterize the molecular pathways underlying persistent monocyte activation in treated HIV patients, through the implication of the activation of the inflammasome machinery: 1. Characterization of NOD like Receptor (NLR) expression in monocytes for IL-1b and IL-18 secretion (inflammasome activation); 2. Characterization of circulating metabolites that active the inflammasome machinery; 3. Evaluation of the link between the activation of the inflammasome, the increased of circulating metabolites and the non-AIDS related comorbidities.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Bordeaux, 프랑스
- Service d'immunologie
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
HIV patients :
Inclusion Criteria:
- Aged 18 years and above
- HIV-1 infected patients
- Enrolled in the CIADIS substudy of the ANRS CO3 Aquitaine cohort
- Patients receiving antiretroviral therapy
- HIV-1 RNA load below the detection limit of 40 copies/mL
- With a written and signed informed consent
Exclusion Criteria:
- HIV-2 or HIV-1/HIV-2 co-infection
Control patients :
Inclusion Criteria:
- Aged 18 years and above
Exclusion Criteria:
- HIV-1, HIV-2 or HIV-1/HIV-2 infection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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HIV 환자
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47ml blood (40 ml EDTA whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and 7 ml for serum).
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대조군 환자
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47ml blood (40 ml EDTA whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and 7 ml for serum).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Characterization of NLR (s) implicated in IL-18 up-regulation (inflammasome activation) in HIV
기간: At baseline (D0)
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At baseline (D0)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Characterization of circulating metabolites that active the inflammasome machinery
기간: At baseline (D0)
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At baseline (D0)
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Non-AIDS related comorbidities
기간: At baseline (D0)
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metabolites of interest, inflammasome activation measured by IL-1b and IL-18
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At baseline (D0)
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Linda WITTKOP, MD, PhD, Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux
- 수석 연구원: Isabelle PELLEGRIN, MD, PhD, University Hospital, Bordeaux
- 연구 책임자: Benjamin FAUSTIN, PhD, Centre National de la Recherche Scientifique, France
간행물 및 유용한 링크
일반 간행물
- Furman D, Chang J, Lartigue L, Bolen CR, Haddad F, Gaudilliere B, Ganio EA, Fragiadakis GK, Spitzer MH, Douchet I, Daburon S, Moreau JF, Nolan GP, Blanco P, Dechanet-Merville J, Dekker CL, Jojic V, Kuo CJ, Davis MM, Faustin B. Expression of specific inflammasome gene modules stratifies older individuals into two extreme clinical and immunological states. Nat Med. 2017 Feb;23(2):174-184. doi: 10.1038/nm.4267. Epub 2017 Jan 16.
- Ozanne A, Duffau P, Dauchy FA, Rigothier C, Terrien C, Lazaro E, Cazanave C, Lawson-Ayayi S, Bonnet F, Blanco P, Wittkop L, Pellegrin I; CIADIS sub-study in the ANRS CO3 Aquitaine cohort study group. Activation, senescence and inflammation markers in HIV patients: association with renal function. AIDS. 2017 May 15;31(8):1119-1128. doi: 10.1097/QAD.0000000000001461.
- Duffau P, Wittkop L, Lazaro E, le Marec F, Cognet C, Blanco P, Moreau JF, Dauchy FA, Cazanave C, Vandenhende MA, Bonnet F, Thiebaut R, Pellegrin I; ANRS CO3 Aquitaine Cohort Study Group. Association of immune-activation and senescence markers with non-AIDS-defining comorbidities in HIV-suppressed patients. AIDS. 2015 Oct 23;29(16):2099-108. doi: 10.1097/QAD.0000000000000807.
- Wittkop L, Bitard J, Lazaro E, Neau D, Bonnet F, Mercie P, Dupon M, Hessamfar M, Ventura M, Malvy D, Dabis F, Pellegrin JL, Moreau JF, Thiebaut R, Pellegrin I; Groupe d'Epidemiologie Clinique du SIDA en Aquitaine. Effect of cytomegalovirus-induced immune response, self antigen-induced immune response, and microbial translocation on chronic immune activation in successfully treated HIV type 1-infected patients: the ANRS CO3 Aquitaine Cohort. J Infect Dis. 2013 Feb 15;207(4):622-7. doi: 10.1093/infdis/jis732. Epub 2012 Nov 29.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUBX 2016/14
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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blood sample에 대한 임상 시험
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Haydarpasa Numune Training and Research Hospital완전한
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University Hospital, Rouen아직 모집하지 않음
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Ischemia Care LLC완전한허혈성 뇌졸중 | 심방세동 | 혈전성 뇌졸중 | 일시적인 허혈 발작 | 심장색전성 뇌졸중 | 뇌저동맥의 뇌졸중 | 일시적인 뇌혈관 사건미국
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Applied Science & Performance Institute완전한