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Interaction Between HIV and Lymphatic Filariasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295698
First Posted: February 24, 2006
Last Update Posted: February 24, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Danish Council for Development Research
The AIDS Foundation, Denmark
The Wedell-Wedellsborg Foundation, Denmark
Information provided by:
DBL -Institute for Health Research and Development
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Studies on the Interaction Between HIV Infection, Lymphatic Filariasis and Diethylcarbamazine

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00295698     History of Changes
Other Study ID Numbers: RUF 91088
First Submitted: February 23, 2006
First Posted: February 24, 2006
Last Update Posted: February 24, 2006
Last Verified: February 2006

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

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Filariasis
Elephantiasis
Elephantiasis, Filarial
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Diethylcarbamazine
Filaricides
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors