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

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

Sponsors

Lead Sponsor: Michael Hoelscher

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

Source Ludwig-Maximilians - University of Munich
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.

Overall Status Active, not recruiting
Start Date October 15, 2017
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Broadly HIV-1 neutralizing antibodies (bNAb) December 31, 2018
Secondary Outcome
Measure Time Frame
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
Enrollment 500
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: NIMR-Mbeya Medical Research Center (MMRC)
Location Countries

Tanzania

Verification Date

August 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Ludwig-Maximilians - University of Munich

Investigator Full Name: Michael Hoelscher

Investigator Title: Professor Dr.

Has Expanded Access No
Condition Browse
Acronym bNAb
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov