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CompletedNCT00295698Updated Feb 24, 2006

Interaction Between HIV and Lymphatic Filariasis

An interventional study of Diethylcarbamazine in HIV Infection and Lymphatic Filariasis, sponsored by DBL -Institute for Health Research and Development. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-02-24.

Sponsored by DBL -Institute for Health Research and Development · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • HIV Infection
  • Lymphatic Filariasis

Keywords

  • HIV
  • Lymphatic filariasis
  • Diethylcarbamazine
  • Interaction
  • Tanzania
03

In context

HIV Infections

4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.

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Lead sponsor

DBL -Institute for Health Research and Development is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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Inclusion criteria

One of the three following conditions:

  1. Positivity for antibodies to -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

Exclusion Criteria:

  1. AIDS
  2. Hydrocele
  3. Lymphoedema
  4. Elephantiasis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double

Interventions

06

Study locations

No study locations are listed for this record.

07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2001 and a completion of Nov 2002. It does not say whether these dates are actual or estimated.

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Registered
Feb 23, 2006
First posted
Feb 24, 2006
Start
Aug 2001
Completion
Nov 2002
Last update
Feb 24, 2006
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Feb 24, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00295698
Lead sponsor
DBL -Institute for Health Research and Development
Collaborators
Danish Council for Development Research, The AIDS Foundation, Denmark, The Wedell-Wedellsborg Foundation, Denmark
First posted
Feb 24, 2006
Start date
Aug 2001
Completion
Nov 2002
Last update
Feb 24, 2006

Study contacts

Nina O Nielsen, Ms.c
principal investigator · DBL -Institute for Health Research and Development
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Diethylcarbamazine

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