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

HIV/AIDS Clinical Trial

— CYSTINET_Tz  

Official title:

The Burden of (Neuro)Cysticercosis Among People Living With HIV Compared With HIV-negative Individuals in the Rural Southern Highlands in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851419
• Other study ID #: CYSTINET-Africa Tz II
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cysticercosis
• HIV/AIDS
• Neurocysticercosis

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