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

Active, not recruiting

• Conditions: HIV/AIDS

• Registration Number: NCT03334552
• Lead Sponsor: Michael Hoelscher

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-15
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-05
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Broadly HIV-1 neutralizing antibodies (bNAb)	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

Secondary Outcome Measures

Name	Time	Method
To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers	December 31, 2018
To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer	December 31, 2018
To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)	December 31, 2018

Trial Locations

Locations (1)

NIMR-Mbeya Medical Research Center (MMRC); 🇹🇿 Mbeya, Tanzania