Vicente Ferrer HIV队列研究 (VFHCS)
2023年3月28日 更新者：Gerardo Alvarez-Uria、Rural Development Trust Hospital
VFHCS 是一项针对来自印度资源贫乏的农村地区的 HIV 感染患者的长期前瞻性队列研究。
该研究的目的是使用从常规临床护理中收集的数据来描述研究人员地区的 HIV 流行病学及其相关状况，并研究“真实世界”环境中健康干预措施的有效性（实施和运筹学）。
研究概览
详细说明
安得拉邦是印度艾滋病毒负担最重的邦。 Anantapur 是位于安得拉邦南部边界的一个地区，拥有 72% 的农村人口，成人识字率为 74.1%，男性为 54.3%，女性为 54.3%。 在安纳塔普尔，艾滋病毒流行主要由异性传播驱动，其特点是社会经济条件差和文盲率高。
Rural Development Trust (RDT) 是一个非政府组织，免费为 HIV 感染者提供医疗服务，包括药物、咨询和入院费。 在 Bathalapalli 医院，门诊部和 71 张病床专供 HIV 或肺结核感染者使用。
Vicente Ferrer HIV 队列研究 (VFHCS) 是一项前瞻性开放队列研究，对象是所有曾就诊于 Bathalapalli RDT 医院的 HIV 感染者。 自 2009 年 9 月以来，前瞻性地收集患者的常规临床数据，并使用 C# 作为前端输入到 SQL 服务器数据库中。 传播途径的详细信息、与 HIV 相关的风险因素和社会人口统计数据在注册时收集。 收集的数据包括药物治疗（抗逆转录病毒治疗和其他药物治疗）、实验室检查（血象、肾功能检查、肝功能检查、CD4 淋巴细胞计数、细菌感染）和标准化诊断。
VFHCS 的目标是描述研究人员环境中与 HIV 相关的社会和医学方面，包括：
- 流行病学：艾滋病毒发病率趋势、传播机制、与艾滋病毒相关的社会经济风险因素。
- 机会性感染的发生率和流行率，尤其是结核病和隐球菌病。
- 预期寿命和与死亡率相关的因素
- 描述整个护理过程中的保留情况，并调查与失访相关的因素。
- 抗逆转录病毒疗法的毒性和有效性。
- 预防母婴传播方案的有效性。
- 癌症或心血管疾病等非传染性疾病的发病率和流行率。
研究类型
观察性的
注册 (预期的)
30000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Gerardo Alvarez-Uria
- 邮箱：hivbtp@gmail.com
学习地点
-
-
AP
-
Battalapalli、AP、印度、515661
- 招聘中
- RDT Hospital
-
接触：
- Gerardo Alvarez Uria, MD PhD
- 邮箱：hivbtp@gmail.com
-
首席研究员：
- Gerardo Alvarez-Uria
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
HIV感染者
描述
纳入标准：
- HIV 血清学阳性
排除标准：
- 拒绝同意
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
死亡
大体时间：将使用事件时间方法。从 HIV 诊断到死亡，将跟踪参与者，评估长达 30 年
|
诊断为 HIV 感染后的生存期
|
将使用事件时间方法。从 HIV 诊断到死亡，将跟踪参与者，评估长达 30 年
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gerardo Alvarez-Uria、Rural Development Trust
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Alvarez-Uria G, Midde M, Pakam R, Naik PK. Gender differences, routes of transmission, socio-demographic characteristics and prevalence of HIV related infections of adults and children in an HIV cohort from a rural district of India. Infect Dis Rep. 2012 Feb 17;4(1):e19. doi: 10.4081/idr.2012.e19. eCollection 2012 Jan 2.
- Alvarez-Uria G, Naik PK, Pakam R, Midde M. Early HIV viral load determination after initiating first-line antiretroviral therapy for indentifying patients with high risk of developing virological failure: data from a cohort study in a resource-limited setting. Trop Med Int Health. 2012 Sep;17(9):1152-5. doi: 10.1111/j.1365-3156.2012.02982.x. Epub 2012 Apr 5.
- Alvarez-Uria G, Midde M, Pakam R, Kannan S, Bachu L, Naik PK. Factors Associated with Late Presentation of HIV and Estimation of Antiretroviral Treatment Need according to CD4 Lymphocyte Count in a Resource-Limited Setting: Data from an HIV Cohort Study in India. Interdiscip Perspect Infect Dis. 2012;2012:293795. doi: 10.1155/2012/293795. Epub 2012 Apr 24.
- Alvarez-Uria G, Midde M, Pakam R, Bachu L, Naik PK. Effect of Formula Feeding and Breastfeeding on Child Growth, Infant Mortality, and HIV Transmission in Children Born to HIV-Infected Pregnant Women Who Received Triple Antiretroviral Therapy in a Resource-Limited Setting: Data from an HIV Cohort Study in India. ISRN Pediatr. 2012;2012:763591. doi: 10.5402/2012/763591. Epub 2012 Jun 3.
- Revell AD, Wang D, Wood R, Morrow C, Tempelman H, Hamers RL, Reiss P, van Sighem AI, Nelson M, Montaner JS, Lane HC, Larder BA; RDI Data and Study Group. An update to the HIV-TRePS system: the development and evaluation of new global and local computational models to predict HIV treatment outcomes, with or without a genotype. J Antimicrob Chemother. 2016 Oct;71(10):2928-37. doi: 10.1093/jac/dkw217. Epub 2016 Jun 20.
- Alvarez-Uria G, Midde M, Naik PK. Mortality in HIV-infected patients with tuberculosis treated with streptomycin and a two-week intensified regimen: data from an HIV cohort study using inverse probability of treatment weighting. PeerJ. 2016 May 17;4:e2053. doi: 10.7717/peerj.2053. eCollection 2016.
- Alvarez-Uria G, Midde M, Pakam R, Yalla PS, Naik PK, Reddy R. Short-Course Induction Treatment with Intrathecal Amphotericin B Lipid Emulsion for HIV Infected Patients with Cryptococcal Meningitis. J Trop Med. 2015;2015:864271. doi: 10.1155/2015/864271. Epub 2015 Sep 10.
- Alvarez-Uria G, Pakam R, Midde M, Yalla PS, Naik PK. Adding Streptomycin to an Intensified Regimen for Tuberculous Meningitis Improves Survival in HIV-Infected Patients. Interdiscip Perspect Infect Dis. 2015;2015:535134. doi: 10.1155/2015/535134. Epub 2015 Aug 4.
- Alvarez-Uria G, Pakam R, Midde M, Naik PK. Incidence and mortality of tuberculosis before and after initiation of antiretroviral therapy: an HIV cohort study in India. J Int AIDS Soc. 2014 Dec 9;17(1):19251. doi: 10.7448/IAS.17.1.19251. eCollection 2014.
- Alvarez-Uria G, Pakam R, Naik PK, Midde M. Induction with lopinavir-based treatment followed by switch to nevirapine-based regimen versus non-nucleoside reverse transcriptase inhibitors-based treatment for first line antiretroviral therapy in HIV infected children three years and older. PLoS One. 2014 Sep 18;9(9):e108063. doi: 10.1371/journal.pone.0108063. eCollection 2014.
- Alvarez-Uria G, Midde M, Pakam R, Naik PK. Directly-observed intermittent therapy versus unsupervised daily regimen during the intensive phase of antituberculosis therapy in HIV infected patients. Biomed Res Int. 2014;2014:937817. doi: 10.1155/2014/937817. Epub 2014 Jun 11.
- Alvarez-Uria G, Naik PK, Midde M, Pakam R. Mortality and Loss to Follow up Before Initiation of Antiretroviral Therapy Among HIV-Infected Children Eligible for HIV Treatment. Infect Dis Rep. 2014 May 13;6(2):5167. doi: 10.4081/idr.2014.5167. eCollection 2014 May 13.
- Alvarez-Uria G. Description of the cascade of care and factors associated with attrition before and after initiating antiretroviral therapy of HIV infected children in a cohort study in India. PeerJ. 2014 Mar 13;2:e304. doi: 10.7717/peerj.304. eCollection 2014.
- Alvarez-Uria G, Naik PK, Midde M, Pakam R. Predictors of loss to follow-up after engagement in care of HIV-infected children ineligible for antiretroviral therapy in an HIV cohort study in India. Germs. 2014 Mar 3;4(1):9-15. doi: 10.11599/germs.2014.1049. eCollection 2014 Mar.
- Alvarez-Uria G, Pakam R, Midde M, Naik PK. Optimal Duration of Daily Antituberculosis Therapy before Switching to DOTS Intermittent Therapy to Reduce Mortality in HIV Infected Patients: A Duration-Response Analysis Using Restricted Cubic Splines. Int Sch Res Notices. 2014 Dec 15;2014:704980. doi: 10.1155/2014/704980. eCollection 2014.
- Alvarez-Uria G, Naik PK, Midde M, Pakam R. Predictors of delayed entry into medical care of children diagnosed with HIV infection: data from an HIV cohort study in India. ScientificWorldJournal. 2013 Nov 14;2013:737620. doi: 10.1155/2013/737620. eCollection 2013.
- Alvarez-Uria G, Pakam R, Midde M, Naik PK. Predictors of delayed antiretroviral therapy initiation, mortality, and loss to followup in HIV infected patients eligible for HIV treatment: data from an HIV cohort study in India. Biomed Res Int. 2013;2013:849042. doi: 10.1155/2013/849042. Epub 2013 Oct 29.
- Revell AD, Wang D, Wood R, Morrow C, Tempelman H, Hamers R, Alvarez-Uria G, Streinu-Cercel A, Ene L, Wensing A, Reiss P, van Sighem AI, Nelson M, Emery S, Montaner JS, Lane HC, Larder BA; RDI Study Group. An update to the HIV-TRePS system: the development of new computational models that do not require a genotype to predict HIV treatment outcomes. J Antimicrob Chemother. 2014 Apr;69(4):1104-10. doi: 10.1093/jac/dkt447. Epub 2013 Nov 24.
- Revell AD, Alvarez-Uria G, Wang D, Pozniak A, Montaner JS, Lane HC, Larder BA. Potential impact of a free online HIV treatment response prediction system for reducing virological failures and drug costs after antiretroviral therapy failure in a resource-limited setting. Biomed Res Int. 2013;2013:579741. doi: 10.1155/2013/579741. Epub 2013 Sep 24.
- Alvarez-Uria G, Midde M, Pakam R, Naik PK. Diagnostic and Prognostic Value of Serum Albumin for Tuberculosis in HIV Infected Patients Eligible for Antiretroviral Therapy: Datafrom an HIV Cohort Study in India. Bioimpacts. 2013;3(3):123-8. doi: 10.5681/bi.2013.025. Epub 2013 Sep 1.
- Alvarez-Uria G, Midde M, Pakam R, Naik PK. Predictors of attrition in patients ineligible for antiretroviral therapy after being diagnosed with HIV: data from an HIV cohort study in India. Biomed Res Int. 2013;2013:858023. doi: 10.1155/2013/858023. Epub 2013 Aug 29.
- Alvarez-Uria G, Naik PK, Pakam R, Midde M. Factors associated with attrition, mortality, and loss to follow up after antiretroviral therapy initiation: data from an HIV cohort study in India. Glob Health Action. 2013 Sep 12;6:21682. doi: 10.3402/gha.v6i0.21682.
- Alvarez-Uria G, Midde M, Pakam R, Naik PK. Initial Antituberculous Regimen with Better Drug Penetration into Cerebrospinal Fluid Reduces Mortality in HIV Infected Patients with Tuberculous Meningitis: Data from an HIV Observational Cohort Study. Tuberc Res Treat. 2013;2013:242604. doi: 10.1155/2013/242604. Epub 2013 Aug 20.
- Alvarez-Uria G, Pakam R, Midde M, Naik PK. Entry, Retention, and Virological Suppression in an HIV Cohort Study in India: Description of the Cascade of Care and Implications for Reducing HIV-Related Mortality in Low- and Middle-Income Countries. Interdiscip Perspect Infect Dis. 2013;2013:384805. doi: 10.1155/2013/384805. Epub 2013 Jul 10.
- Alvarez-Uria G. Factors associated with delayed entry into HIV medical care after HIV diagnosis in a resource-limited setting: Data from a cohort study in India. PeerJ. 2013 Jun 18;1:e90. doi: 10.7717/peerj.90. Print 2013.
- Revell AD, Wang D, Wood R, Morrow C, Tempelman H, Hamers RL, Alvarez-Uria G, Streinu-Cercel A, Ene L, Wensing AM, DeWolf F, Nelson M, Montaner JS, Lane HC, Larder BA; RDI study group. Computational models can predict response to HIV therapy without a genotype and may reduce treatment failure in different resource-limited settings. J Antimicrob Chemother. 2013 Jun;68(6):1406-14. doi: 10.1093/jac/dkt041. Epub 2013 Mar 13.
- Alvarez-Uria G, Naik PK, Pakam R, Bachu L, Midde M. Natural History and Factors Associated with Early and Delayed Mortality in HIV-Infected Patients Treated of Tuberculosis under Directly Observed Treatment Short-Course Strategy: A Prospective Cohort Study in India. Interdiscip Perspect Infect Dis. 2012;2012:502012. doi: 10.1155/2012/502012. Epub 2012 Dec 18.
- Alvarez-Uria G, Azcona JM, Midde M, Naik PK, Reddy S, Reddy R. Rapid Diagnosis of Pulmonary and Extrapulmonary Tuberculosis in HIV-Infected Patients. Comparison of LED Fluorescent Microscopy and the GeneXpert MTB/RIF Assay in a District Hospital in India. Tuberc Res Treat. 2012;2012:932862. doi: 10.1155/2012/932862. Epub 2012 Aug 26.
- Alvarez-Uria G, Midde M, Naik PK. Socio-demographic Risk Factors Associated with HIV Infection In Patients Seeking Medical Advice in a Rural Hospital of India. J Public Health Res. 2012 Feb 14;1(1):79-82. doi: 10.4081/jphr.2012.e14. eCollection 2012 Feb 17.
- Alvarez-Uria G, Naik PK, Midde M, Kannan S, Reddy R. False negative HIV antibody test in HIV infected children who receive early antiretroviral treatment in a resource-limited setting. Infect Dis Rep. 2012 Jan 4;4(1):e6. doi: 10.4081/idr.2012.e6. eCollection 2012 Jan 2.
- Alvarez-Uria G, Reddy R, Reddy S, Naik PK, Midde M. Evaluation of a Low-Cost Strategy for Enumerating CD4 Lymphocyte Absolute Count and Percentage Using the FACSCalibur Flow Cytometer in HIV-Infected Patients from a Resource-Limited Setting. ISRN AIDS. 2012 Oct 23;2012:494698. doi: 10.5402/2012/494698. eCollection 2012.
- Alvarez-Uria G, Midde M, Naik PK. Trends and risk factors for HIV infection among young pregnant women in rural India. Int J Infect Dis. 2012 Feb;16(2):e121-3. doi: 10.1016/j.ijid.2011.10.003. Epub 2011 Dec 5.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年9月1日
初级完成 (预期的)
2039年9月1日
研究完成 (预期的)
2040年1月1日
研究注册日期
首次提交
2015年5月15日
首先提交符合 QC 标准的
2015年5月26日
首次发布 (估计)
2015年5月27日
研究记录更新
最后更新发布 (实际的)
2023年3月29日
上次提交的符合 QC 标准的更新
2023年3月28日
最后验证
2023年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.