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Interaction Between HIV and Lymphatic Filariasis
This study has been completed.
Sponsors and Collaborators: DBL -Institute for Health Research and Development
Danish Council for Development Research
The AIDS Foundation, Denmark
The Wedell-Wedellsborg Foundation, Denmark
Information provided by: DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier: NCT00295698
  Purpose

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.


Condition Intervention
HIV Infection
Lymphatic Filariasis
Drug: Diethylcarbamazine

Genetics Home Reference related topics: lymphedema-distichiasis syndrome
MedlinePlus related topics: AIDS
Drug Information available for: Diethylcarbamazine Diethylcarbamazine citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Studies on the Interaction Between HIV Infection, Lymphatic Filariasis and Diethylcarbamazine

Further study details as provided by DBL -Institute for Health Research and Development:

Study Start Date: August 2001
Estimated Study Completion Date: November 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

One of the three following conditions:

  1. Positivity for antibodies to HIV-1 or HIV-2
  2. Positivity for circulating filarial antigen from W. bancrofti
  3. Positivity for both HIV antibodies and W.bancrofti circulating antigens

Exclusion Criteria:

  1. AIDS
  2. Hydrocele
  3. Lymphoedema
  4. Elephantiasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295698

Sponsors and Collaborators
DBL -Institute for Health Research and Development
Danish Council for Development Research
The AIDS Foundation, Denmark
The Wedell-Wedellsborg Foundation, Denmark
Investigators
Principal Investigator: Nina O Nielsen, Ms.c DBL -Institute for Health Research and Development
  More Information

Study ID Numbers: RUF 91088
Study First Received: February 23, 2006
Last Updated: February 23, 2006
ClinicalTrials.gov Identifier: NCT00295698  
Health Authority: Tanzania: National Institute for Medical Research

Keywords provided by DBL -Institute for Health Research and Development:
HIV
Lymphatic filariasis
Diethylcarbamazine
Interaction
Tanzania

Study placed in the following topic categories:
Diethylcarbamazine
Lymphatic filariasis
Sexually Transmitted Diseases, Viral
Elephantiasis, Filarial
Acquired Immunodeficiency Syndrome
Filariasis
Nematode Infections
Immunologic Deficiency Syndromes
Virus Diseases
Lymphedema
Lymphatic Diseases
HIV Infections
Sexually Transmitted Diseases
Parasitic Diseases
Retroviridae Infections
Helminthiasis

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Filaricides
Anthelmintics
Enzyme Inhibitors
Infection
Lipoxygenase Inhibitors
Pharmacologic Actions
Spirurida Infections
Antiparasitic Agents
Therapeutic Uses
Lentivirus Infections
Elephantiasis
Antinematodal Agents
Secernentea Infections

ClinicalTrials.gov processed this record on January 16, 2009