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Interaction Between HIV and Lymphatic Filariasis

Primary Purpose

HIV Infection, Lymphatic Filariasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diethylcarbamazine
Sponsored by
DBL -Institute for Health Research and Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, Lymphatic filariasis, Diethylcarbamazine, Interaction, Tanzania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: One of the three following conditions: Positivity for antibodies to HIV-1 or HIV-2 Positivity for circulating filarial antigen from W. bancrofti Positivity for both HIV antibodies and W.bancrofti circulating antigens Exclusion Criteria: AIDS Hydrocele Lymphoedema Elephantiasis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2006
    Last Updated
    February 23, 2006
    Sponsor
    DBL -Institute for Health Research and Development
    Collaborators
    Danish Council for Development Research, The AIDS Foundation, Denmark, The Wedell-Wedellsborg Foundation, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00295698
    Brief Title
    Interaction Between HIV and Lymphatic Filariasis
    Official Title
    Studies on the Interaction Between HIV Infection, Lymphatic Filariasis and Diethylcarbamazine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    DBL -Institute for Health Research and Development
    Collaborators
    Danish Council for Development Research, The AIDS Foundation, Denmark, The Wedell-Wedellsborg Foundation, Denmark

    4. Oversight

    5. Study Description

    Brief Summary
    The impact of lymphatic filariasis (LF) on HIV is assessed by measuring HIV viral load before and after DEC treatment of filariasis in double-infected individuals. The impact of HIV on lymphatic filariasis is assessed by measuring the success of DEC treatment on W. bancrofti antigenaemia and microfilaraemia in double-infected individuals. The effect of DEC treatment in individuals with lymphatic filariasis and/or HIV is assessed by measuring the pre- and post-treatment level of HIV viral load, immunological responses and micronutritional parameters, including antioxidants and markers of oxidative stress, in single- or double-infected individuals. The study is carried out as an anonymous, unlinked and double-blind placebo controlled study with cross-over design. The study groups comprise: 1) 18 double-infected individuals (HIV+/LF+), 2) 16 HIV infected individuals (HIV+/LF-) and 3) 25 individuals with lymphatic filariasis (HIV-/LF+). Based on stratified, blocked randomisation the study participants receive DEC treatment or placebo. Pre- and post-treatment (1 week, 12 weeks and 24 weeks post-treatment) blood samples are collected and analysed for HIV viral load, CD4+ T cell count, distinctive Th1 and Th2 cytokines, circulating filarial antigens (CFA), micronutrient status, antioxidant enzymes and markers of oxidative stress. After 12 weeks the study participants get the opposite treatment and post-treatment blood samples are collected four times with the same intervals as above.
    Detailed Description
    Previous studies on the interaction between HIV and helminth infections have indicated that HIV may have a negative impact on helminth infections and vice versa, and there is evidence that treatment of chronic helminth infections in HIV infected individuals can delay the progression of HIV. These interactions may be related to changes in the immunological responsiveness or through an effect on reactive oxygen compounds resulting in oxidative stress. Oxidative stress may be a neglected determinant for progression of lymphatic filariasis and may also impair immune functions and lead to increased HIV replication through activation of nuclear transcription factors. The present study examines the three-way interaction between HIV infection, lymphatic filariasis caused by the helminth parasite W. bancrofti and the drug diethylcarbamazine (DEC). DEC is an important drug for treatment of lymphatic filariasis and previous findings indicate that DEC may also have an effect on retroviral infections. The impact of lymphatic filariasis (LF) on HIV is assessed by measuring HIV viral load before and after DEC treatment of filariasis in double-infected individuals. The impact of HIV on lymphatic filariasis is assessed by measuring the success of DEC treatment on W. bancrofti antigenaemia and microfilaraemia in double-infected individuals. The effect of DEC treatment in individuals with lymphatic filariasis and/or HIV is assessed by measuring the pre- and post-treatment level of HIV viral load, immunological responses and micronutritional parameters, including antioxidants and markers of oxidative stress, in single- or double-infected individuals. The study is carried out as an anonymous, unlinked and double-blind placebo controlled study with cross-over design. The study groups comprise: 1) 18 double-infected individuals (HIV+/LF+), 2) 16 HIV infected individuals (HIV+/LF-) and 3) 25 individuals with lymphatic filariasis (HIV-/LF+). Based on stratified, blocked randomisation the study participants receive DEC treatment or placebo. Pre- and post-treatment (1 week, 12 weeks and 24 weeks post-treatment) blood samples are collected and analysed for HIV viral load, CD4+ T cell count, distinctive Th1 and Th2 cytokines, circulating filarial antigens (CFA), micronutrient status, antioxidant enzymes and markers of oxidative stress. After 12 weeks the study participants get the opposite treatment and post-treatment blood samples aree collected four times with the same intervals as above. If treatment of coexisting helminth infections, including lymphatic filariasis, delays the progression of HIV, such treatment may be an important measure to alleviate the effect of the AIDS epidemic in Africa and other areas where HIV and helminths coexist. For lymphatic filariasis in particular such information will be of high significance in the strategic planning by decision-makers within the ongoing international efforts for control of lymphatic filariasis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection, Lymphatic Filariasis
    Keywords
    HIV, Lymphatic filariasis, Diethylcarbamazine, Interaction, Tanzania

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Diethylcarbamazine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: One of the three following conditions: Positivity for antibodies to HIV-1 or HIV-2 Positivity for circulating filarial antigen from W. bancrofti Positivity for both HIV antibodies and W.bancrofti circulating antigens Exclusion Criteria: AIDS Hydrocele Lymphoedema Elephantiasis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nina O Nielsen, Ms.c
    Organizational Affiliation
    DBL -Institute for Health Research and Development
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Interaction Between HIV and Lymphatic Filariasis

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