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临床试验/NCT01541631
NCT01541631Unknown不适用

Epidemiology of Human Immunodeficiency Virus (HIV-1) and Schistosoma Mansoni Co-infections and Its Impact on Anthelminthic Treatment Outcome Among HIV-1 Infected Individuals in Fishing Communities in Mwanza Region, Northwestern Tanzania.

Catholic University of Health and Allied Sciences2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
2
主要终点
The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni

研究概览

简要总结

In this study, it is hypothesized that helminth infections modulate immune responses against HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of helminth infections on progression of HIV-1 infection is dependent on helminth infection intensity, host background immunity, nutritional status, demographic factors and socio-economic status. Also, treatment of helminth infections using praziquantel and albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads, improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is associated with poor anthelminthic treatment outcome as compared to non-HIV infected individuals

详细描述

The proposed study has the main objective to investigate the epidemiology of HIV-1 and Schistosoma mansoni co-infections and assess their association and progress of HIV positive individuals co-infected with S. mansoni. The study will also assess the impact of praziquantel treatment on S. mansoni related morbidities in co-infected HIV positive individuals with S. mansoni in Fishing villages, northwest Tanzania. The study is designed as a community based intervention trial, which consist of cross-sectional survey at the initial baseline survey followed by intervention trials. The initial baseline survey will include 2000 participants from the two villages. The objective of the survey is to determine the prevalence of HIV-1 infection and haemoglobin levels. Also, the socio-economic, demographic characteristics, individual behaviour in relation to HIV-1 and helminth transmission are recorded. In addition, the location and altitude of each household will determined using a hand-held Garmin GPSmap 60CSX, which has an accuracy of ± 5m. After initial survey, study participant will be grouped into 2 groups, one HIV-1 infected group and HIV-1 uninfected group. Blood sample for examination of CD4+, CD4+/CD8+ and HIV-1 viral loads will be obtained from HIV-1 positive participants every month for a period of six month. After 6 month of prospective longitudinal survey, the first follow-up survey of the recruited study participants will be conducted with the objective of determining prevalence and intensity of human intestinal schistosomiasis and other helminth infections. Other infections will also be examined, includes malaria and viral hepatitis. Furthermore, S. mansoni induced morbidity will be examined using ultrasonography. A blood sample will also be obtained for all HIV-1 positive patients, from which CD4+, CD4+/CD8+ and HIV-1 viral loads will be examined. In the same survey, individuals who tested HIV-1 negative at baseline will also be screened for HIV. After the first follow-up survey, three groups will be formed, Group A- individuals co-infected with HIV-1 and S. mansoni (N=270); Group B- individuals infected with HIV-1 but S. mansoni negative (N=180) and Group C- HIV-1 negative but S. mansoni positive (N=1320) (Figure 2). All individuals who will be infected with S. mansoni and other helminth detected in the study irrespective of HIV-1 serostatus will be treated with praziquantel (40mg/kg) and albendazole (400mg). At six to eight weeks after mass treatment, a second survey will be conducted in the recruited participants aiming at determining cure rates of S. mansoni after chemotherapy with praziquantel. The third survey will be conducted 12 month after the first follow-up survey with the aim of determining the change in CD4+, CD4+/CD8+, HIV-1 viral loads, HIV-1 progression and reversibility of the S. mansoni related liver morbidity after praziquantel

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent residents and those who have lived in the village for more than 2 years.
  • HIV-1 positive individuals only those with CD4+ ≥ 400 cells/μl

排除标准

  • HIV-1 positive individuals with CD4+ < 350 cells/μl,
  • Those who are on antiretroviral therapy (ARV)
  • Pregnant women are excluded.
  • Participants with chronic diseases such as leukemia, tuberculosis and viral hepatitis

研究组 & 干预措施

HIV-1 co-infected with schistosoma mansoni

Experimental

HIV-1 patients co-infected with Schistosoma mansoni

干预措施: Praziquantel and Albendazole (Drug)

HIV-1 positive individuals with negative S. mansoni

No Intervention

HIV-1 positive individuals with negative Schistosoma mansoni

干预措施: Praziquantel and Albendazole (Drug)

Schistosoma mansoni positive but HIV-1 negative

Experimental

Schistosoma mansoni positive individuals but HIV-1 negative to be compared with HIV-1 co-infected with Schistosoma mansoni individuals

干预措施: Praziquantel and Albendazole (Drug)

HIV-1 and Schistosoma mansoni negative

No Intervention

Individuals with no HIV-1 and S. mansoni infections

干预措施: Praziquantel and Albendazole (Drug)

结局指标

主要结局

The impact of Praziquantel in HIV-1 individuals co-infected with Schistosoma mansoni

时间窗: 12 month follow-up

* Impact of praziquantel treatment on CD4+,CD4+/CD8+, HIV-1 viral loads haemoglobin level, reversibility of liver pathology and occurance of opportunistic infection * Prevalence of co-infections of HIV-1 and Schistosoma mansoni * Prospective longitudinal association between HIV-1 and S. mansoni, and the progression of HIV to AIDS, according to S. mansoni infection status.

次要结局

  • Efficacy of praziquantel(12 months)

研究者

发起方
Catholic University of Health and Allied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Humphrey Mazigo, Msc, MPH

Epidemiology of Human Immunodeficiency Virus (HIV-1) and Schistosoma mansoni co-infections and its impact on anthelminthic treatment outcome among HIV-1 infected individuals in fishing communities in Mwanza region, Northwestern Tanzania.

Makerere University

研究点 (2)

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