Clinical trial NCT03334552: Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
Official title: Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV/AIDS
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research - Mbeya Medical Research Centre (NIMR-MMRC)
name: University Clinic of Cologne, Department of Internal Medicine, Center for Molecular Medicine Cologne (CMMC)
name: Max von Pettenkofer-Institute of the University of Munich (LMU), Department of Virology
First posted: 2017-11-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Broadly HIV-1 neutralizing antibodies (bNAb)
timeFrame: December 31, 2018
Secondary outcomes:
measure: To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer
timeFrame: December 31, 2018
measure: To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers
timeFrame: December 31, 2018
measure: To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)
timeFrame: December 31, 2018
Other outcomes:
Locations:
city: Mbeya
country: Tanzania
facility: NIMR-Mbeya Medical Research Center (MMRC)
Study officials:
affiliation: Medical Center of the University of Munich, Division of Infectious Diseases and Tropical Medicine, Germany
name: Arne Kroidl, Dr.
role: STUDY_CHAIR
affiliation: NIMR-Mbeya Medical Research Center (MMRC), Tazania
name: Wiston William, Dr.
role: PRINCIPAL_INVESTIGATOR
References: