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Interaction Between HIV and Lymphatic Filariasis

NCT00295698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2006-02-24

No results posted yet for this study

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.

Conditions

  • HIV Infection
  • Lymphatic Filariasis

Interventions

DRUG

Diethylcarbamazine

Sponsors & Collaborators

  • Danish Council for Development Research

    collaborator OTHER

  • The AIDS Foundation, Denmark

    collaborator OTHER

  • The Wedell-Wedellsborg Foundation, Denmark

    collaborator UNKNOWN

  • DBL -Institute for Health Research and Development

    lead OTHER

Principal Investigators

  • Nina O Nielsen, Ms.c · DBL -Institute for Health Research and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Completion
2002-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295698 on ClinicalTrials.gov