- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01519141
Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection
Immunologic and Inflammatory Factors and Cardiovascular Risk in Patients With HIV Infection or Autoimmune Diseases
This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviors. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years.
Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry.
To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV positive and negative patients with cardiac disease, the investigators will use 48-hour Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery hypertension for the presence of cardiac arrhythmia.
The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography) will be used to detect and quantify inflammation in the body.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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San Francisco, California, 미국, 94110
- University of California San Francisco, San Francisco General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Stable antiretroviral therapy for at least 12 months, and have no immediate plans to alter therapy.
- All plasma HIV RNA levels within the past year must be below conventional levels of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 1000 copies will be allowed if they were preceded and followed by undetectable viral load determinations.
- Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
HIV-negative controls
HIV-negative individuals
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HIV-infected patients
HIV-infected patients who are on a stable antiretroviral drug regimen for at least a year; all plasma HIV RNA levels within the past year must be below conventional levels of detection (< 50 copies RNA/mL).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
carotid intima-media thickness
기간: 2 years
|
Increased carotid intima-media thickness (mm)
|
2 years
|
brachial artery flow-mediated dilatation
기간: 2 years
|
decreased brachial artery flow-mediated dilatation (%)
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2 years
|
D-dimer
기간: 2 years
|
Increased D-dimer levels (mcg/mL)
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2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Priscilla Hsue, MD, University of California, San Francisco
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .