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Changes in HIV Viral Load in Patients Undergoing Treatment for Filariasis

Changes in HIV Viral Load in Patients Undergoing Treatment for Filarial Infection

This study, sponsored by the National Institutes of Health and the Tuberculosis Research Centre and YRG-Care in Chennai, India, will examine how treatment of lymphatic filariasis in HIV-infected patients influences the amount of HIV virus in the blood and the progression of HIV infection to AIDS. Filarial infections are common in Chennai, and it is important to understand whether treatment of filariasis affects the course of HIV disease. The information gained from this study could be used to modify treatments for people both with HIV and filarial infections.

Patients 18 years of age and older who are receiving treatment for HIV infection at the Government Hospital HIV clinic or YRG-Care may be eligible for this study. Two groups of patients will be recruited - patients with both HIV and filarial infections, and patients who have HIV infection alone, without filariasis. Candidates are screened with a medical history and review of medical records, physical examination, and blood and stool tests. Women have a urine pregnancy test.

Within one month of screening, all participants receive a single dose of diethylcarbamazine and albendazole, a drug regimen commonly used to treat filarial infection. Patients are followed closely for the first 2 weeks after treatment to check for side effects. They are then seen at 1, 3, 6 and 12 months after the treatment dose for a physical examination and blood test.

研究概览

地位

完全的

详细说明

To determine the effect of pre-existing filarial infection and its treatment on viral burden and clinical parameters in patients infected with HIV, this study aims to follow plasma HIV loads, CD4 counts, and clinical parameters in a population of HIV-infected individuals co-infected with Wuchereria bancrofti, prior to and after treatment of filarial infection. The study individuals will be drawn from the patient cohort followed by the HIV Clinic at the Government General Hospital and the Tuberculosis Research Centre, Chennai, India, or those from YRG-Care (Chennai, India), an area endemic for lymphatic filariasis (LF) and where the prevalence of HIV infection in the general population is about 7%. These patients are adults of all ages, both males and females, come from the states of Tamil Nadu and Andhra Pradhesh. Having established as part of a previous protocol (01-I-N022) an HIV/filarial coprevalence of 6-10% based on W. bancrofti circulating antigen detection in HIV-positive and -negative individuals, patients in whom co-infection with HIV and LF has been diagnosed will be paired with two HIV-positive (but filarial antigen negative) clinic controls matched for age, gender, viral load antiretroviral therapy and CD4 count. All efforts will be made to connect study participants with programs for antiretroviral distribution. Within a month of a baseline clinical evaluation, patients and controls will receive a single dose of the combination of diethylcarbamazine/albendazole (the drug combination given as part of national campaigns to eliminate LF) and will then be followed with viral loads, CD4 counts and clinical examinations at one week, as well as 1, 3, 6 and 12 months after the administration. By assessing these changes, the influence of a co-existing filarial infection on plasma HIV viral load, CD4 count and clinical course can be determined. At the end of the study period, all participants will be re-assessed for filarial antibody and antigen to ensure absence of the parasite. Any patient who has evidence of ongoing filarial infection with W. bancrofti will be re-treated with DEC/albendazole.

研究类型

观察性的

注册 (预期的)

1000

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。

学习地点

      • Chennai、印度
        • Government General Hospital
      • Chennai、印度
        • Tuberculosis Research Centre
      • Chennai、印度
        • YRG Care

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

Greater than 18 years of age.

Ability to give informed consent

HIV positive

If on antiretrovirals or treatment for opportunistic infections, have it be a stable maintenance period of at least 2 months

Male or female, providing women are neither pregnant nor breast-feeding

Willingness to adhere to the testing schedule of the protocol and to provide small amounts of blood (5 ml) on multiple occasions

Willingness to be treated with DEC/albendazole

Willingness, if female, to be tested for pregnancy and to be informed of the test result

Willingness to have samples stored for future research

EXCLUSION CRITERIA:

Acutely ill at the time of enrollment into the study i.e. newly diagnosed with an opportunistic infection and not yet stabilized on a treatment regime.

Hemoglobin less than 9 g/l for women and less than 10 g/l for men

AST, ALT greater than 5 times normal

Evidence of acute HIV infection (acute antiretroviral syndrome)

Active tuberculosis or known tuberculosis

A true allergy to DEC or albendazole

At the discretion of the investigator if it is felt that someone is not appropriate for the study (i.e. known active drug use, patient with history of chronic noncompliance in clinic visits)

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?

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。

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。

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

2005年8月8日

初级完成

2022年12月7日

研究完成

2012年1月31日

研究注册日期

首次提交

2006年6月23日

首先提交符合 QC 标准的

2006年6月23日

首次发布 (估计)

2006年6月26日

研究记录更新

最后更新发布 (实际的)

2017年7月2日

上次提交的符合 QC 标准的更新

2017年6月30日

最后验证

2012年1月31日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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