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German Centre for Infection Research HIV Translational Platform

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ClinicalTrials.gov Identifier: NCT02149004
Recruitment Status : Recruiting
First Posted : May 29, 2014
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
German Center for Infection Research
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Dr. med. Jörg Janne Vehreschild, University Hospital of Cologne

Brief Summary:

Despite major advances in therapy and management, HIV/AIDS continues to be a major cause of infectious disease morbidity and mortality on a global scale. The discovery of effective antiretroviral treatment has turned HIV infection into a manageable chronic disease in most patients with access to care. However, the different economic and epidemiologic situation in developing and developed countries requires different research priorities, so that three main challanges are universal and in focus of research of the DZIF HIV Translational Platform:

  • Prevention of HIV infection
  • Long-term life with HIV
  • HIV cure

The "Translation Reserach HIV" will bring together clinical researchers in HIV infection in order to develop new treatment options to the above mentioned main challanges. It will take advantage of existing expertise (e.g. basic science, novel targets for treatment and HIV eradiation) of the partner sites. This platform is necessary because Germany's HIV research has suffered in the past from a lack of integration between its excellent basic science and clinical research. In addition, there was too little integration into networks that address the main international challenges. There is an urgent need to link these research strands through dedicated structures emphasising the translation of preclinical results into new therapies.


Condition or disease
HIV

Detailed Description:

Structure

The DZIF HIV Translational Platform belongs to the HIV the Thematic Translational Units (TTUs) of the German Centre for Infection Research (DZIF), which is founded by the Federal Ministry of Education and Research (BMBF). The national, multi-centre structure of the DZIF bringing together selceted universities, university hospitals, and non-university research institutes and translational efforts focussing on distinct infectious diesease-related health problems are co-ordinated by the TTUs. The TTU HIV is located in six DZIF partner sites in Germany: Bonn-Cologne, Brunswick-Hannover, Gießen-Marburg-Langen, Hamburg, Heidelberg, Munich.

Mission and Objectives

Prevention of HIV:

The main tools for effective prevention include vaccines, microbicides, preventive therapy and induction of behavioral change. Currently, few groups in Germany have specific preclinical expertise in this area. This expertise needs to be further developed and integrated in the DZIF to be able to implement internationally competitive HIV vaccine and microbicide programmes.

Long-term life with HIV:

This challenge is equally relevant for the developing and developed world. DZIF researchers have made many internationally visible contributions to management of HIV infection in the past. They have extensive experience in clinical studies in the HIV field and have played a major role in the clinical development of new drugs for HIV therapy (e.g. maraviroc, raltegravir). They are also intensively involved in the establishment of clinical guidelines for management of HIV infection.

HIV cure:

Antiretroviral therapy can completely suppress HIV replication below the limit of detection for sustained periods of time, but cannot eradicate the virus from silent reservoirs. Accordingly, life-long therapy is needed and interruption of therapy always leads to resurgence of viral spread and disease. Several approaches have been suggested to eliminate silently infected cells or the HIV genomes integrated in these cells. These approaches are currently mostly at the stage of basic research or early preclinical development and need to be developed in the translational chain. While significant knowledge exists about the nature of silent reservoirs, the number and clonality of viral integration sites is currently largely unknown and needs to be further investigated to develop virus eradication strategies and therapies.

The aim of the DZIF HIV Translational Platform is to comprehensively and collaboratively analyze the above mentioned aspects by using cohorts of HIV infected patients in different stages and with different courses of disease. These cohorts have been established by the participating partner sites, which will be coordinated and extended by the focus site in Bonn-Cologne.

This study protocol is the framework and platform for future substudies.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Translational Research Platform of the TTU HIV of the German Center for Infection Research (DZIF)
Study Start Date : April 2015
Estimated Primary Completion Date : January 2035
Estimated Study Completion Date : January 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Site Bonn
Site Heidelberg
Site Munich
Site Hamburg
Site Hannover
Site Cologne
Site Freiburg
Site Frankfurt
Site Essen



Primary Outcome Measures :
  1. Incidence of new HIV infections in Germany [ Time Frame: Up to 20 years ]
    Overall long-term goal of the platform is to develop a translation strategy for the preclinical results concerning HIV prevention from all German research groups with outstanding expertise. Specific outcome measures will be detailed in future subprojects.


Secondary Outcome Measures :
  1. Incidence of chronic organ failure and malignant diseases in HIV infected patients [ Time Frame: Up to 20 years ]
    Overall long-term goal of this platform is to focus on co-infections, organ damage and malignant diseases. Research on identifying new correlates of protection and long term viral control will contribute to improved management of HIV infection. Specific outcome measures will be detailed in future subprojects.


Other Outcome Measures:
  1. Sustained viral response rate 12 months after discontinuation of ART [ Time Frame: Up to 20 years ]
    Overall long-term goal of this platform is to eliminate silently infected cells or the HIV genomes integrated in these cells. These approaches are currently mostly at the stage of basic research or early preclinical development and need to be developed in the translational chain. Specific outcome measures will be detailed in future subprojects.


Biospecimen Retention:   Samples With DNA
Liquids, tissue, and pathogens from consenting patients will be stored in a decentral biobank.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients HIV positive and who are treated in one of the six partner sites
Criteria

Inclusion Criteria:

  • HIV positive

Exclusion Criteria:

  • None

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): NCT02149004


Contacts
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Contact: Jörg Janne Vehreschild, MD +49 221 478 86973 janne.vehreschild@ctuc.de
Contact: Gerd Fätkenheuer, MD +49 221 478 3324 g.faetkenheuer@uni-koeln.de

Locations
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Germany
University Hospital of Cologne Recruiting
Cologne, North Rhine-Westphalia, Germany, 50931
Contact: Jörg Janne Vehreschild, MD    +49 221 478 86973    janne.vehreschild@ctuc.de   
Principal Investigator: Jörg Janne Vehreschild, MD         
Sponsors and Collaborators
University Hospital of Cologne
German Center for Infection Research
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Jörg Janne Vehreschild, MD University Hospital of Cologne
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Jörg Janne Vehreschild, Coordinating Investigator, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT02149004    
Other Study ID Numbers: DZIF_HIV
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Dr. med. Jörg Janne Vehreschild, University Hospital of Cologne:
Human immunodeficiency virus (HIV)
Prevention
Long-term life
Cure
Cohort
Additional relevant MeSH terms:
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Infection