NeurocysticercosisCYSTINET_TzNCT03851419
The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania
An observational study of Neurocysticercosis and HIV/AIDS, run by Technical University of Munich at 1 site in Tanzania.
Trial summary
This study aims to compare the burden of neurocysticercosis among people living with HIV to people not infected with HIV. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocysticercosis, HIV/AIDS
- What is being tested?
- Diagnosis of (Neuro)cysticercosis
- How many people
- 2,584 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Apr 2018to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Burden of (Neuro)Cysticercosis Among People Living With HIV Compared With HIV-negative Individuals in the Rural Southern Highlands in Tanzania
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.
- Conditions
- Neurocysticercosis, HIV/AIDS
- Being tested
- Diagnosis of (Neuro)cysticercosis
- Medical subject headings
- Neurocysticercosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of (Neuro)cysticercosisDiagnostic test
- Serological tests for cysticercosis
- Neurological examination and cerebral CT scan for the diagnosis of neurocysticercosis
- Stool testing for T. solium
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV | People living with HIV (ART naive or on ART) Receives: 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 Receives: Diagnostic Test: Diagnosis of (Neuro)cysticercosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cysticercosis
Prevalence of cysticercosis among people living with HIV and matched HIV-negative individuals in rural Tanzania where pig farming is common
Measured: 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
Measured: 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.
Measured: One time assessment through immunological testing at inclusion into study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Apr 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kilimanjaro Clinical Research Institute, Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Bernard J Ngowi, MD, PhD, Principal investigator, National Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851419
- Sponsor's protocol ID
- CYSTINET-Africa Tz II
- Acronym
- CYSTINET_Tz
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of (Neuro)Cysticercosis Among People Living With HIV Compared With HIV-negative Individuals in the Rural Southern Highlands in Tanzania
- ClinicalTrials.gov ID
- NCT03851419
- Acronym / sponsor ID
- CYSTINET_Tz / CYSTINET-Africa Tz II
- Conditions
- Neurocysticercosis, HIV/AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,584 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Kilimanjaro Clinical Research Institute, Muhimbili University of Health and Allied Sciences
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with HIV | – | Diagnostic Test: Diagnosis of (Neuro)cysticercosisPeople living with HIV (ART naive or on ART) |
| People not infected with HIV | – | Diagnostic Test: Diagnosis of (Neuro)cysticercosisHIV-negative people. Each participant is matched for age, sex and location to a study participant living with HIV |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of (Neuro)cysticercosis* Serological tests for cysticercosis * Neurological examination and cerebral CT scan for the diagnosis of neurocysticercosis * Stool testing for T. solium | Diagnostic test | People living with HIV, People not infected with HIV |
Primary outcome
Prevalence of cysticercosis
Time frame: 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
Time frame: 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
1 secondary outcome
Th1 cytokines among neurocysticercosis patients
Time frame: One time assessment through immunological testing at inclusion into study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Neurocysticercosis
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
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Oxfendazole in Mild Parenchymal Brain Cysticercosis
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The Impact of Medical TV Drama in Improving Literacy on Neurocysticercosis
Neurocysticercosis, Health Literacy
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Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard J Ngowi, MD, PhD principal investigator
National Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocysticercosis and HIV/AIDS, run by Technical University of Munich at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cysticercosis (time frame: Single assessment at inclusion into study (serological testing)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.