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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	11 December 2023
Main ID:	NCT03334552
Date of registration:	03/11/2017
Prospective Registration:	No
Primary sponsor:	Michael Hoelscher
Public title:	Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania. bNAb
Scientific title:	Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
Date of first enrolment:	October 15, 2017
Target sample size:	500
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03334552
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Tanzania

Contacts

Name:	Arne Kroidl, Dr.
Address:
Telephone:
Email:
Affiliation:	Medical Center of the University of Munich, Division of Infectious Diseases and Tropical Medicine, Germany

Name:	Wiston William, Dr.
Address:
Telephone:
Email:
Affiliation:	NIMR-Mbeya Medical Research Center (MMRC), Tazania

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV/AIDS

Intervention(s)

Primary Outcome(s)

Broadly HIV-1 neutralizing antibodies (bNAb) [Time Frame: December 31, 2018]

Secondary Outcome(s)

To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer [Time Frame: December 31, 2018]

To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance) [Time Frame: December 31, 2018]

To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers [Time Frame: December 31, 2018]

Secondary ID(s)

LMU-IMPH-bNAb

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Clinic of Cologne, Department of Internal Medicine, Center for Molecular Medicine Cologne (CMMC)

National Institute for Medical Research - Mbeya Medical Research Centre (NIMR-MMRC)

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

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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