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

Completed

• Conditions: HIV/AIDS; Neurocysticercosis
• Interventions: Diagnostic Test: Diagnosis of (Neuro)cysticercosis

• Registration Number: NCT03851419
• Lead Sponsor: Technical University of Munich

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2584

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People living with HIV	Diagnosis of (Neuro)cysticercosis	People living with HIV (ART naive or on ART)
People not infected with HIV	Diagnosis of (Neuro)cysticercosis	HIV-negative people. Each participant is matched for age, sex and location to a study participant living with HIV

Primary Outcome Measures

Name	Time	Method
Prevalence of cysticercosis	Single assessment at inclusion into study (serological testing)	Prevalence of cysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common
Prevalence of neurocysticercosis	Single assessment through cerebral CT scan at inclusion into study	Prevalence of neurocysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common

Secondary Outcome Measures

Name	Time	Method
Th1 cytokines among neurocysticercosis patients	One time assessment through immunological testing at inclusion into study	To compare the specific peripheral immune response against T. solium neurocysticercosis between symptomatic and asymptomatic patients measured by concentration of Th1 cytokines.

Trial Locations

Locations (1)

National Institute of Medical Research; 🇹🇿 Dar Es Salaam, Tanzania