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Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.

NCT ID: NCT03334552

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-15

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Voluntary and informed consent
2. ≥18 years of age
3. Documented HIV infection.
4. Willing to consent to active tracing including home tracing

Exclusion Criteria

1. 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.
2. Prisoners
3. 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)
4. Unlikely to comply with protocol as judged by the principal investigator or his designate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Medical Research - Mbeya Medical Research Centre (NIMR-MMRC)

UNKNOWN

Sponsor Role collaborator

University Clinic of Cologne, Department of Internal Medicine, Center for Molecular Medicine Cologne (CMMC)

UNKNOWN

Sponsor Role collaborator

Max von Pettenkofer-Institute of the University of Munich (LMU), Department of Virology

UNKNOWN

Sponsor Role collaborator

Michael Hoelscher

OTHER

Sponsor Role lead

Responsible Party

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Michael Hoelscher

Professor Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arne Kroidl, Dr.

Role: STUDY_CHAIR

Medical Center of the University of Munich, Division of Infectious Diseases and Tropical Medicine, Germany

Wiston William, Dr.

Role: PRINCIPAL_INVESTIGATOR

NIMR-Mbeya Medical Research Center (MMRC), Tazania

Locations

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NIMR-Mbeya Medical Research Center (MMRC)

Mbeya, , Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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LMU-IMPH-bNAb

Identifier Type: -

Identifier Source: org_study_id