Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334552
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Michael Hoelscher, 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.

Condition or disease
HIV/AIDS

Layout table for study information
Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Broadly HIV-1 neutralizing antibodies (bNAb) [ Time Frame: 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 :
  1. To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer [ Time Frame: December 31, 2018 ]
  2. To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers [ Time Frame: December 31, 2018 ]
  3. To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance) [ Time Frame: December 31, 2018 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334552


Locations
Layout table for location information
Tanzania
NIMR-Mbeya Medical Research Center (MMRC)
Mbeya, Tanzania
Sponsors and Collaborators
Michael Hoelscher
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
Investigators
Layout table for investigator information
Study Chair: Arne Kroidl, Dr. Medical Center of the University of Munich, Division of Infectious Diseases and Tropical Medicine, Germany
Principal Investigator: Wiston William, Dr. NIMR-Mbeya Medical Research Center (MMRC), Tazania
Layout table for additonal information
Responsible Party: Michael Hoelscher, Professor Dr., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT03334552    
Other Study ID Numbers: LMU-IMPH-bNAb
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases