AzTrials
AzTrials

HIV InfectionNCT00295698

Interaction Between HIV and Lymphatic Filariasis

A study testing Diethylcarbamazine in people with HIV Infection and Lymphatic Filariasis, run by DBL -Institute for Health Research and Development.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection, Lymphatic Filariasis
What is being tested?
Diethylcarbamazine
How many people
Not given
Where
No sites listed yet
Study dates
Aug 2001to Nov 2002
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • AIDS
  • Hydrocele
  • Lymphoedema
  • Elephantiasis

About this study

Official title: Studies on the Interaction Between HIV Infection, Lymphatic Filariasis and Diethylcarbamazine

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.

Being tested
Diethylcarbamazine
Keywords
HIV, Lymphatic filariasis, Diethylcarbamazine, Interaction, Tanzania
Medical subject headings
HIV Infections, Elephantiasis, Filarial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiethylcarbamazineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2006 (estimated)
  2. Study startAug 2001
  3. Study completionNov 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295698
Sponsor's protocol ID
RUF 91088
Status last verified
Feb 2006
First submitted
23 Feb 2006
Last updated
24 Feb 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Diethylcarbamazine in people with HIV Infection and Lymphatic Filariasis, run by DBL -Institute for Health Research and Development.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2006.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in