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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03851419
Other study ID # CYSTINET-Africa Tz II
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date April 30, 2021

Study information

Verified date November 2023
Source Technical University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 2584
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility 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 - HIV-positive patients - Patient suspected of taeniasis or cysticercosis/neurocysticercosis 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Diagnosis of (Neuro)cysticercosis
Serological tests for cysticercosis Neurological examination and cerebral CT scan for the diagnosis of neurocysticercosis Stool testing for T. solium

Locations

Country Name City State
Tanzania National Institute of Medical Research Dar Es Salaam

Sponsors (4)

Lead Sponsor Collaborator
Technical University of Munich Kilimanjaro Clinical Research Institute, Muhimbili University of Health and Allied Sciences, National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of cysticercosis Prevalence of cysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common Single assessment at inclusion into study (serological testing)
Primary Prevalence of neurocysticercosis Prevalence of neurocysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common Single assessment through cerebral CT scan at inclusion into study
Secondary 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. One time assessment through immunological testing at inclusion into study
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