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

NCT03334552 | Unknown

• 1 other identifier: LMU-IMPH-bNAb
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  December 31, 2018

Secondary Outcomes (3)

• To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer

  December 31, 2018

• To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers

  December 31, 2018

• To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)

  December 31, 2018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Voluntary and informed consent
• ≥18 years of age
• Documented HIV infection.
• Willing to consent to active tracing including home tracing

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Hoelscher: lead
• National Institute for Medical Research - Mbeya Medical Research Centre (NIMR-MMRC): collaborator
• University Clinic of Cologne, Department of Internal Medicine, Center for Molecular Medicine Cologne (CMMC): collaborator
• Max von Pettenkofer-Institute of the University of Munich (LMU), Department of Virology: collaborator

Study Sites (1)

NIMR-Mbeya Medical Research Center (MMRC)

Mbeya, Tanzania

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Arne Kroidl, Dr.

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

  STUDY CHAIR

• Wiston William, Dr.

  NIMR-Mbeya Medical Research Center (MMRC), Tazania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: October 15, 2017
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

TA (1)