HAART associated body shape & metabolic changes in India

HAART 相关体型

基本信息

批准号：
7650317
负责人：
SUNEETA SAGHAYAM
金额：
$ 5.12万
依托单位：
YRG CENTRE FOR AIDS RESEARCH & EDUCATION
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-08-24 至 2013-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7650317
关键词：
Address Albumins Anthropometry Anti-Retroviral Agents Asia Atrophic Bion Body Composition Body fat Body mass index Bone Density Bone Mineral Contents C-reactive protein CD4 Lymphocyte Count Cardiovascular Diseases Caring Clinic Consent Data Deposition Developed Countries Developing Countries Drops Enrollment Evolution Fasting Fatty acid glycerol esters General Population Generic Drugs Glucose Glucose Intolerance HIV HIV Infections HIV Seropositivity HIV prevention trials network High Density Lipoprotein Cholesterol Highly Active Antiretroviral Therapy Hour India Individual Insulin Insulin Resistance LDL Cholesterol Lipoproteins Lamivudine Limb structure Lipids Longitudinal Studies Measures Metabolic Methods Nutritional Nutritional status OGTT Patients Population Prevalence Randomized Recruitment Activity Reporting Research Design Research Personnel Resources Role Serum Shapes Skin Stavudine Study Subject Suggestion Testing Time Triceps Brachii Muscle Viral Load result Zidovudine base bone cohort efavirenz fasting glucose glucose tolerance high risk improved meetings non-nucleoside reverse transcriptase inhibitors programs prospective response subcutaneous trend waist circumference

项目摘要

Objective: To evaluate the initial response to EFV-based HAART and the evolution of those changes over time on HAART in HIV infected previously ART-naive patients in South India. Comparison with a matched, untreated group will allow us to differentiate the role of antiretrovirals versus the natural progression of HIV infection on the nutritional status, metabolic, body shape, body composition and bone parameters. These data have not been previously reported from Asia. Specific Aim I: In the treatment group, a)To describe the nutritional, body shape and metabolic responses to the initiation of therapy (EFV-HAART) between baseline and 6 months; b)To describe the evolution of nutritional, body shape and metabolic response to continuous HAART therapy between 6-36 months Specific Aim II: In the untreated group, to describe the evolution of body composition and lipid changes with the natural progression of HIV infection (subjects must maintain CD4 between 300-500, if GD4 drops <200, therapy will be initiated and subjects will be withdrawn from the study). Study design: A 36 months prospective longitudinal study where study subjects recruited by HPTN study #052 with CD4 between 300 - 500 are randomized to either receive HAART treatment or remain untreated. All subjects in HPTN 052 will be asked to provide consent to enroll in this study in which they will be followed every 6 months for 3 years to observe body shape and metabolic changes Methods: Body shape and body composition changes will be assessed using anthropometry, BIA (every 6 months) and DEXA (yearly). Metabolic changes will be evaluated every 6 months by fasting lipids, insulin, glucose and 2hr glucose (yearly). Fasting lactate and C-reactive protein will also be measured every 6 months.

目的：评估印度南部感染 HIV 且未接受过 ART 的患者对基于 EFV 的 HAART 的初步反应以及这些变化随着时间的推移在 HAART 上的演变。与匹配的未治疗组进行比较将使我们能够区分抗逆转录病毒药物与 HIV 感染自然进展对营养状况、代谢、体型、身体成分和骨骼参数的作用。亚洲此前并未报道过这些数据。具体目标 I：在治疗组中，a) 描述基线至 6 个月期间对开始治疗 (EFV-HAART) 的营养、体型和代谢反应； b) 描述 6-36 个月期间连续 HAART 治疗的营养、体型和代谢反应的演变具体目标 II：在未治疗组中，描述随着 HIV 感染的自然进展，身体成分和脂质变化的演变（受试者必须将CD4维持在300-500之间，如果GD4下降<200，则将开始治疗并且受试者将从研究中退出）。研究设计：一项为期 36 个月的前瞻性纵向研究，HPTN 研究 #052 招募的 CD4 介于 300 - 500 之间的研究对象被随机分配接受 HAART 治疗或不接受治疗。 HPTN 052 中的所有受试者都将被要求同意参加这项研究，他们将每 6 个月接受一次随访，持续 3 年，以观察体型和代谢变化。方法：将使用人体测量学、BIA 来评估体型和身体成分变化（每 6 个月）和 DEXA（每年）。每 6 个月将通过空腹血脂、胰岛素、葡萄糖和 2 小时葡萄糖（每年）评估代谢变化。每 6 个月还会测量一次空腹乳酸和 C 反应蛋白。