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

HIV/AIDS Clinical Trial

— bNAb  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03334552
• Other study ID #: LMU-IMPH-bNAb
• Status: Active, not recruiting
• Start date: October 15, 2017
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Locations

Country	Name	City	State
Tanzania	NIMR-Mbeya Medical Research Center (MMRC)	Mbeya

Sponsors (4)

Lead Sponsor	Collaborator
Michael Hoelscher	Max von Pettenkofer-Institute of the University of Munich (LMU), Department of Virology, 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)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer		December 31, 2018
Secondary	To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers		December 31, 2018
Secondary	To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)		December 31, 2018