ClinicalTrials.gg
CompletedNCT03851419CYSTINET_TzUpdated Nov 29, 2023

The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania

An observational study in Neurocysticercosis and HIV/AIDS, sponsored by Technical University of Munich. Completed at 1 site in Tanzania. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Technical University of Munich · Observational

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,584
Ages
14 Years and older
Sex
All
01

Study summary

This study aims to compare the burden of neurocysticercosis among people living with HIV to people not infected with HIV.

Read the detailed description

People living with HIV and matched HIV negative controls will be tested serologically for cysticercosis, examined neurologically and will undergo CT scanning to determine the prevalence and presentation of NCC.

Furthermore, the immune system response in HIV patients with Taenia solium neurocysticercosis will be assessed.

02

Conditions studied

  • Neurocysticercosis
  • HIV/AIDS
03

In context

Neurocysticercosis

21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.

Browse Neurocysticercosis studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 322 studies on the registry; 60 are open to participants now.

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

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

1000 patients from HIV clinics will be recruited at the study sites in Mbeya and Iringa region. For each HIV-positive patient an HIV-negative control matched by age, sex and location will be included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who consent to participate in the study and testing.
  • Patients of age 14 years and above
  • Patient living inside the study catchment area
  • -positive patients
  • Patient suspected of taeniasis or cysticercosis/neurocysticercosis

Exclusion criteria

Exclusion Criteria:

  • Patients with opportunistic infections.
  • Study participants taking anthelminthic drugs PZQ and ALB or have received them within the previous 12 months.
  • Pregnant women
  • Patients that are seriously ill.
  • Patients with epilepsy and other mental disorders that impair thoughts and emotions such as psychosis.
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.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,584 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • People living with HIV

    People living with HIV (ART naive or on ART)

    Diagnostic Test: Diagnosis of (Neuro)cysticercosis

  • People not infected with HIV

    HIV-negative people. Each participant is matched for age, sex and location to a study participant living with HIV

    Diagnostic Test: Diagnosis of (Neuro)cysticercosis

Interventions

  • Diagnostic testDiagnosis of (Neuro)cysticercosis

    * Serological tests for cysticercosis * Neurological examination and cerebral CT scan for the diagnosis of neurocysticercosis * Stool testing for T. solium

06

What researchers measure

Primary outcomes

  1. Prevalence of cysticercosis

    Prevalence of cysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common

    Time frame: Single assessment at inclusion into study (serological testing)

  2. Prevalence of neurocysticercosis

    Prevalence of neurocysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common

    Time frame: Single assessment through cerebral CT scan at inclusion into study

Secondary outcomes

  1. Th1 cytokines among neurocysticercosis patients

    To compare the specific peripheral immune response against T. solium neurocysticercosis between symptomatic and asymptomatic patients measured by concentration of Th1 cytokines.

    Time frame: One time assessment through immunological testing at inclusion into study

07

Study locations

1 site
  • National Institute of Medical Research
    Dar Es Salaam, Tanzania
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Apr 2021, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2019
First posted
Feb 22, 2019
StartActual
Apr 1, 2018
Primary completionActual
Apr 30, 2021
CompletionActual
Apr 30, 2021
Last update
Nov 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
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.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03851419
Collaborators
National Institute for Medical Research, Tanzania, Kilimanjaro Clinical Research Institute, Muhimbili University of Health and Allied Sciences
Responsible party
Sponsor
First posted
Feb 22, 2019
Start date
Apr 1, 2018
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
Nov 29, 2023

Study contacts

Bernard J Ngowi, MD, PhD
principal investigator · National Institute for Medical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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