- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00050908
Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs
Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Endothelial dysfunction, assessed by measurement of brachial artery reactivity, is associated with coronary artery disease. Previous studies showed that patients taking HIV protease inhibitors (PIs) had a buildup of fatty deposits in their arteries and impaired flow-mediated vasodilation of the brachial artery, whereas endothelial function was normal in HIV-infected individuals not taking PIs. The effect of three different antiretroviral regimens on endothelial function in antiretroviral naïve HIV-infected patients will be examined in this substudy.
Patients in this substudy will have Brachial Artery Reactivity Tests (BARTs), which are painless ultrasound tests of an artery in the lower arm. Brachial artery reactivity will be measured at entry and at 4 and 24 weeks after patients are randomized to one of three open-label drug regimens in ACTG A5142. Brachial artery reactivity in response to two vasoactive stimuli (flow-mediated and nitroglycerin) will be assessed by measuring brachial artery diameter and flow velocity. Blood will be drawn at Weeks 4 and 24 for insulin and lipid tests. Patients will fast and refrain from tobacco and caffeine use for at least 8 hours prior to each study visit. For the duration of the substudy, patients will be asked not to change the amount of fruits, juices, antioxidants, and tea that they consume.
Type d'étude
Inscription
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095-1793
- UCLA School of Med
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San Diego, California, États-Unis, 92103
- Univ of California, San Diego Antiviral Research Ctr
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Hawaii
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Honolulu, Hawaii, États-Unis, 96816-2396
- Univ of Hawaii
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Illinois
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Chicago, Illinois, États-Unis, 46202
- Northwestern Univ
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Wishard Hosp
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Indianapolis, Indiana, États-Unis, 46202-5250
- Indiana Univ Hosp
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Indianapolis, Indiana, États-Unis, 46202-5250
- Methodist Hosp of Indiana
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New York
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New York, New York, États-Unis, 10011
- Chelsea Clinic
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Ohio
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Cincinnati, Ohio, États-Unis, 43210-1282
- Univ of Cincinnati
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participation in ACTG A5142 .
- Able and willing to give written informed consent and to report current smoking status.
- Men who have been on stable testosterone replacement for at least 3 months prior to entry and plan to continue to receive a stable dose during the substudy may enroll. Men who have discontinued testosterone therapy must be off for at least 3 months to be eligible.
- Women receiving oral contraceptives, hormone replacement, or progestational derivatives must have been on stable regimens for at least 3 months prior to enrollment and must plan to remain on the same dose for the duration of the study. Women who have discontinued such therapy must be off for at least 3 months to be eligible.
Exclusion Criteria:
- Coronary heart disease, peripheral vascular disease, or cerebrovascular disease.
- Diabetes mellitus, with the exception of a previous history of gestational or steroid-induced diabetes mellitus within 12 weeks prior to substudy entry.
- Insulin-sensitizing agents such as metformin, pioglitazone, and rosiglitazone.
- Lipid-lowering drugs within 6 weeks prior to substudy entry.
- Systemic glucocorticoids, long-acting inhaled steroids, and certain anabolic steroids within 30 days prior to substudy entry.
- Uncontrolled hypertension.
- Heavy use of vitamin supplements.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Francesca J. Torriani, M.D., University of California, San Diego
Publications et liens utiles
Publications générales
- Stein JH, Klein MA, Bellehumeur JL, McBride PE, Wiebe DA, Otvos JD, Sosman JM. Use of human immunodeficiency virus-1 protease inhibitors is associated with atherogenic lipoprotein changes and endothelial dysfunction. Circulation. 2001 Jul 17;104(3):257-62. doi: 10.1161/01.cir.104.3.257.
- Behrens G, Schmidt H, Meyer D, Stoll M, Schmidt RE. Vascular complications associated with use of HIV protease inhibitors. Lancet. 1998 Jun 27;351(9120):1958. doi: 10.1016/S0140-6736(98)26026-0. No abstract available.
- Cleland SJ, Sattar N, Petrie JR, Forouhi NG, Elliott HL, Connell JM. Endothelial dysfunction as a possible link between C-reactive protein levels and cardiovascular disease. Clin Sci (Lond). 2000 May;98(5):531-5.
- Henderson A. Endothelial dysfunction: a reversible clinical measure of atherogenic susceptibility and cardiovascular inefficiency. Int J Cardiol. 1997 Dec 1;62 Suppl 1:S43-8. doi: 10.1016/s0167-5273(97)00212-x. No abstract available.
- Wolf K, Tsakiris DA, Weber R, Erb P, Battegay M; Swiss HIV Cohort Study. Antiretroviral therapy reduces markers of endothelial and coagulation activation in patients infected with human immunodeficiency virus type 1. J Infect Dis. 2002 Feb 15;185(4):456-62. doi: 10.1086/338572. Epub 2002 Jan 18.
- Stein JH, Komarow L, Cotter BR, Currier JS, Dube MP, Fichtenbaum CJ, Gerschenson M, Mitchell CK, Murphy RL, Squires K, Parker RA, Torriani FJ; ACTG 5152s Study Team. Lipoprotein Changes in HIV-Infected Antiretroviral-Naive Individuals after Starting Antiretroviral Therapy: ACTG Study A5152s Stein: Lipoprotein Changes on Antiretroviral Therapy. J Clin Lipidol. 2008 Dec;2(6):464-471. doi: 10.1016/j.jacl.2008.08.442.
Dates d'enregistrement des études
Dates principales de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Infections à VIH
Autres numéros d'identification d'étude
- A5152s
- ACTG A5152s
- 10812 (DAIDS ES)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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