Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People
A Comparison of Endothelial Function Between HIV-infected Subjects Not Receiving Antiretroviral Therapy and Matched HIV-uninfected Control Subjects
調査の概要
状態
条件
詳細な説明
Normally the insides of blood vessels either widen or narrow in response to the need for more or less blood flow. This is a function of the endothelial cells, which are the cells that line the inner layer of blood vessels. However, in some people endothelial function is impaired, which may put them at an increased risk of heart disease and stroke. It is widely assumed that HIV-infected people not yet receiving antiretroviral medications experience more impaired endothelial function than HIV-uninfected people, possibly because of the link between HIV and inflammation. However, no rigorously controlled study has yet to be performed to verify this presumption. It is important to establish whether HIV infection itself, and not the use of antiretroviral medications, is indeed the cause of impaired endothelial function. This study will compare endothelial function in people with HIV who are not already receiving antiretroviral medications and in people without HIV. Specifically, inflammation, immune activation, endothelial activation, and metabolic measures will be compared.
This study will involve two groups of participants. The first group will consist of people with HIV who are enrolling in two other separate HIV studies (NCT00864916 and NCT00796822), one lasting 8 weeks and the other lasting 48 weeks. The second group will consist of people without HIV who are similar to the first group in terms of age, sex, smoking status, and height. All HIV-infected participants will undergo assessments during the study visits of whichever other HIV study they are enrolled in. All HIV-uninfected participants will attend a main study visit that will include the following: a review of medical records and family medical history; measurements of blood pressure, heart rate, weight, temperature, and waist and hip circumferences; blood and urine collection; and a procedure called brachial artery reactivity testing, which is a noninvasive way to measure endothelial function. Some of the HIV-uninfected participants will continue in the study so that any changes in their endothelial function can be assessed. They will attend either two additional study visits at Weeks 4 and 8, which will correspond with one of the HIV studies, or three additional study visits at Weeks 8, 24, and 48, which will correspond with the other HIV study. The additional visits will include repeat testing except for blood and urine collection.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Infectious Diseases Research Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria for HIV-Infected Group:
- Positive HIV enzyme-linked immunosorbent assay (ELISA) test with confirmatory Western Blot
- Not currently receiving antiretroviral therapy
Inclusion Criteria for HIV-Uninfected Group:
- Negative HIV ELISA test at screening
- Within 10 years of age of the matched HIV-infected participant
- Same sex and current smoking status as the matched HIV-infected participant
- Height within 4 inches of the matched HIV-infected participant
Exclusion Criteria for All Participants:
- Inability to complete written informed consent
- Incarceration at the time of screening or main study visit
- Diagnosed vascular disease (e.g., history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
- Diagnosed disease or process associated with increased systemic inflammation (e.g., systemic lupus erythematosis, inflammatory bowel diseases, or other collagen vascular diseases); Note: Hepatitis B or C co-infections are not exclusionary
- History of bleeding diathesis, gastrointestinal ulceration or bleeding, cerebrovascular aneurysm or bleeding, or retinal hemorrhage
- Known or suspected cancer requiring systemic treatment within 6 months of screening
- History of diabetes mellitus, as defined by the American Diabetes Association; Note: History of gestational diabetes is not exclusionary
- History of migraine headaches
- History of Raynaud's phenomenon
- History of cardiac arrhythmias or cardiomyopathy
- History of hypothyroidism or hyperthyroidism, even if treated; Note: Use of caffeinated products, except on the mornings of the study visits, is not exclusionary
- Known allergy or intolerance to nitroglycerin
- History of carotid bruits
- Creatinine clearance less than 50mL/min, using a serum creatinine level measured at screening
- Hemoglobin level greater than 9.0g/dL at screening
- Alanine aminotransferase (ALT) level or aspartate aminotransferase (AST) greater than three times the upper limit of normal (ULN) at screening
- Total bilirubin greater than 2.5 times ULN at screening
- Fever, defined as a temperature greater than 38.0 C within 48 hours prior to screening
- Received therapy for acute infection or other serious medical illness within 14 days prior to screening
- Pregnant or breastfeeding during the course of the study
- Hypotension, defined as systolic blood pressure less than 90mm Hg, at screening.
- Uncontrolled hypertension
- Receipt of anti-inflammatory agents (e.g., plaquenil, infliximab, etanercept, mycophenolate mofetil, sirolimus, tacrolimus, cyclosporine, pentoxifylline, thalidomide)
- Receipt of investigational agents, cytotoxic chemotherapy, systemic or topical glucocorticoids (of any dose), or anabolic steroids within 28 days of screening; Note: Physiologic testosterone replacement therapy is not exclusionary
- Receipt of lipid-lowering drugs, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), acetazolamide, anticoagulants, anticonvulsants, or thyroid replacements within 7 days prior to screening
- Use of sildenafil, vardenafil, or tadalafil within 72 hours (before or after) of each main study visit
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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HIV-Infected
HIV-infected participants who are not currently receiving antiretroviral medications
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HIV-Uninfected
HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Endothelial Function (Brachial Artery Reactivity)
時間枠:Single measurement
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The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion.
This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.
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Single measurement
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Samir K. Gupta, MD, MS、Indiana University School of Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIV感染症の臨床試験
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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Helios SaludViiV Healthcareわからない