HIV/AIDSbNAbNCT03334552
Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
An observational study of HIV/AIDS, run by Michael Hoelscher at 1 site in Tanzania.
Trial summary
In natural HIV disease, a small fraction (1-2%) of infected individuals develops exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from these individuals have been shown to be highly active against a broad range of different HIV strains and are therefore called broadly neutralizing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- How many people
- 500 participants
- Where
- 1 siteTanzania
- Study dates
- 15 Oct 2017to Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult HIV-infected, preferentially ART-naïve patients within the Mbeya region. The prevalence of elite neutralizers is expected to be 1-2% from the overall population. The study therefore targets to recruit 500 subjects in order to identify at least 5 elite neutralizers, which will be subjected to further in depth antibody characterization.
Who may be able to join
- Voluntary and informed consent
- ≥18 years of age
- Documented HIV infection.
- Willing to consent to active tracing including home tracing
Who cannot join
- Deficiency, rendering it difficult, if not impossible, to take part in the study or understand the information provided. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
- Prisoners
- If within the discretion of the investigator study participation would possibly add not acceptable risk or burden to patient (e.g. significant health deficiencies, social harm)
- Unlikely to comply with protocol as judged by the principal investigator or his designate
Trial locations and contacts
1 site in 1 country.
About this study
In natural HIV disease, a small fraction (1-2%) of infected individuals develops exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from these individuals have been shown to be highly active against a broad range of different HIV strains and are therefore called broadly neutralizing antibodies (bNAbs). These antibodies are in fact able to prevent (S)HIV infection in animal models and therefore of great interest for the development of an HIV vaccine. Information of neutralizing antibodies in patients from Africa is still scarce and would be of great value in the development of adapted HIV vaccine strategies in these regions. This study aims to investigate African HIV-infected individuals, who have developed neutralizing antibodies using highly specialized laboratory methodologies.
- Conditions
- HIV/AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Broadly HIV-1 neutralizing antibodies (bNAb)
identify HIV-infected patients which exhibit exceptional HIV-1 neutralizing activity (so called elite neutralizer) and to perform in those patients in depth characterization including:
- Detailed analysis of anti-HIV antibody response using single B cell analyis
- Isolation of broadly neutralizing anti-HIV antibodies
- Testing of in vitro neutralizing activity and binding properties of newly identified bNAbs
- Analysis of the antiviral activity and in vivo characteristics of broadly neutralizing antibodies using a HIV-1-infected humanized mouse model
Measured: December 31, 2018
Secondary outcomes (3)
To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer
Measured: December 31, 2018
To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers
Measured: December 31, 2018
To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)
Measured: December 31, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start15 Oct 2017
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Hoelscher
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research - Mbeya Medical Research Centre (NIMR-MMRC), University Clinic of Cologne, Department of Internal Medicine, Center for Molecular Medicine Cologne (CMMC), Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor-investigator, Michael Hoelscher, Ludwig-Maximilians - University of Munich
- Investigators
- Arne Kroidl, Dr., Study chair, Medical Center of the University of Munich, Division of Infectious Diseases and Tropical Medicine, GermanyWiston William, Dr., Principal investigator, NIMR-Mbeya Medical Research Center (MMRC), Tazania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334552
- Sponsor's protocol ID
- LMU-IMPH-bNAb
- Acronym
- bNAb
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2017
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
- ClinicalTrials.gov ID
- NCT03334552
- Acronym / sponsor ID
- bNAb / LMU-IMPH-bNAb
- Conditions
- HIV/AIDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Michael HoelscherUniversity, hospital or other
- Collaborators
- National Institute for Medical Research - Mbeya Medical Research Centre (NIMR-MMRC), University Clinic of Cologne, Department of Internal Medicine, Center for Molecular Medicine Cologne (CMMC), Ludwig-Maximilians - University of Munich
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 7 Nov 2017 (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.
In natural HIV disease, a small fraction (1-2%) of infected individuals develops exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from these individuals have been shown to be highly active against a broad range of different HIV strains and are therefore called broadly neutralizing antibodies (bNAbs). These antibodies are in fact able to prevent (S)HIV infection in animal models and therefore of great interest for the development of an HIV vaccine. Information of neutralizing antibodies in patients from Africa is still scarce and would be of great value in the development of adapted HIV vaccine strategies in these regions. This study aims to investigate African HIV-infected individuals, who have developed neutralizing antibodies using highly specialized laboratory methodologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult HIV-infected, preferentially ART-naïve patients within the Mbeya region. The prevalence of elite neutralizers is expected to be 1-2% from the overall population. The study therefore targets to recruit 500 subjects in order to identify at least 5 elite neutralizers, which will be subjected to further in depth antibody characterization.
Key inclusion criteria (4 listed)
- Voluntary and informed consent
- ≥18 years of age
- Documented HIV infection.
- Willing to consent to active tracing including home tracing
Key exclusion criteria (4 listed)
- Deficiency, rendering it difficult, if not impossible, to take part in the study or understand the information provided. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
- Prisoners
- If within the discretion of the investigator study participation would possibly add not acceptable risk or burden to patient (e.g. significant health deficiencies, social harm)
- Unlikely to comply with protocol as judged by the principal investigator or his designate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Broadly HIV-1 neutralizing antibodies (bNAb)
Time frame: December 31, 2018
identify HIV-infected patients which exhibit exceptional HIV-1 neutralizing activity (so called elite neutralizer) and to perform in those patients in depth characterization including: * Detailed analysis of anti-HIV antibody response using single B cell analyis * Isolation of broadly neutralizing anti-HIV antibodies * Testing of in vitro neutralizing activity and binding properties of newly identified bNAbs * Analysis of the antiviral activity and in vivo characteristics of broadly neutralizing antibodies using a HIV-1-infected humanized mouse model
3 secondary outcomes
To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer
Time frame: December 31, 2018
To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers
Time frame: December 31, 2018
To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)
Time frame: December 31, 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Arne Kroidl, Dr. study chair
Medical Center of the University of Munich, Division of Infectious Diseases and Tropical Medicine, Germany
Wiston William, Dr. principal investigator
NIMR-Mbeya Medical Research Center (MMRC), Tazania
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 HIV/AIDS, run by Michael Hoelscher 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 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?
Results are not available in the source record.
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?
Broadly HIV-1 neutralizing antibodies (bNAb) (time frame: December 31, 2018). 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 28 Nov 2023.