NCT03851419

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.1 years

First QC Date

February 4, 2019

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (1)

  • Th1 cytokines among neurocysticercosis patients

    One time assessment through immunological testing at inclusion into study

Study Arms (2)

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

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

People living with HIVPeople not infected with HIV

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Medical Research

Dar es Salaam, Tanzania

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

NeurocysticercosisAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Central Nervous System HelminthiasisCentral Nervous System Parasitic InfectionsCentral Nervous System InfectionsInfectionsParasitic DiseasesCysticercosisTaeniasisCestode InfectionsHelminthiasisCentral Nervous System DiseasesNervous System DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bernard J Ngowi, MD, PhD

    National Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 22, 2019

Study Start

April 1, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations