HIVNCT02149004
German Centre for Infection Research HIV Translational Platform
An observational study of HIV, run by University Hospital of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Jan 2035
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients HIV positive and who are treated in one of the six partner sites
Who may be able to join
- HIV positive
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50931
Jörg Janne Vehreschild, MD, +49 221 478 86973, janne.vehreschild@ctuc.de
Jörg Janne Vehreschild, MD
About this study
Official title: Translational Research Platform of the TTU HIV of the German Center for Infection Research (DZIF)
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.
Read the 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.
- Conditions
- HIV
- Keywords
- Human immunodeficiency virus (HIV), Prevention, Long-term life, Cure, Cohort
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Site Bonn | Not described | |
| Site Heidelberg | Not described | |
| Site Munich | Not described | |
| Site Hamburg | Not described | |
| Site Hannover | Not described | |
| Site Cologne | Not described | |
| Site Freiburg | Not described | |
| Site Frankfurt | Not described | |
| Site Essen | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new HIV infections in Germany
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.
Measured: Up to 20 years
Secondary outcomes (1)
Incidence of chronic organ failure and malignant diseases in HIV infected patients
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.
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startApr 2015
- Primary completionJan 2035 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research, German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Dr. med. Jörg Janne Vehreschild, University Hospital of Cologne
- Investigators
- Jörg Janne Vehreschild, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149004
- Sponsor's protocol ID
- DZIF_HIV
- Status last verified
- Oct 2017
- First submitted
- 16 May 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ehren K, Hertenstein C, Kummerle T, Vehreschild JJ, Fischer J, Gillor D, Wyen C, Lehmann C, Cornely OA, Jung N, Gravemann S, Platten M, Wasmuth JC, Rockstroh JK, Boesecke C, Schwarze-Zander C, Fatkenheuer G. Causes of death in HIV-infected patients from the Cologne-Bonn cohort. Infection. 2014 Feb;42(1):135-40. doi: 10.1007/s15010-013-0535-7. Epub 2013 Oct 1.
PubMed 24081925Bojti I, Bojtine Kovacs S, Ziegler A, Jung N, Maier A, Westermann D, Funk JL, Mathe P, Fink G, Usadel S, Rieg S, Szabo GT, Czuriga D, Muller MC. Viral suppression is associated with rising NT-proCNP levels and reduced systemic inflammation in people living with HIV. Infection. 2026 May 11. doi: 10.1007/s15010-026-02812-z. Online ahead of print.
PubMed 42113461Trickey A, Ingle SM, Boyd A, Gill MJ, Grabar S, Jarrin I, Obel N, Touloumi G, Zangerle R, Rauch A, Rentsch CT, Satre DD, Silverberg MJ, Bonnet F, Guest J, Burkholder G, Crane H, Teira R, Berenguer J, Wyen C, Abgrall S, Hessamfar M, Reiss P, d'Arminio Monforte A, McGinnis KA, Sterne JAC, Wittkop L; Antiretroviral Therapy Cohort Collaboration. Contribution of alcohol use in HIV/hepatitis C virus co-infection to all-cause and cause-specific mortality: A collaboration of cohort studies. J Viral Hepat. 2023 Sep;30(9):775-786. doi: 10.1111/jvh.13863. Epub 2023 Jun 20.
PubMed 37338017Trickey A, Sabin CA, Burkholder G, Crane H, d'Arminio Monforte A, Egger M, Gill MJ, Grabar S, Guest JL, Jarrin I, Lampe FC, Obel N, Reyes JM, Stephan C, Sterling TR, Teira R, Touloumi G, Wasmuth JC, Wit F, Wittkop L, Zangerle R, Silverberg MJ, Justice A, Sterne JAC. Life expectancy after 2015 of adults with HIV on long-term antiretroviral therapy in Europe and North America: a collaborative analysis of cohort studies. Lancet HIV. 2023 May;10(5):e295-e307. doi: 10.1016/S2352-3018(23)00028-0. Epub 2023 Mar 20.
PubMed 36958365Mathe PJG, Usadel S, Rieg S, Kern WV, Muller MC. Long-term follow-up after introduction of a systematic sexually transmitted infection screening program for men having sex with men living with HIV in a primary care setting: uptake, STI incidence, and risk factors for infection and reinfection. Infection. 2023 Aug;51(4):897-907. doi: 10.1007/s15010-022-01946-0. Epub 2022 Nov 9.
PubMed 36352322Stecher M, Chaillon A, Stephan C, Knops E, Kohmer N, Lehmann C, Eberle J, Bogner J, Spinner CD, Eis-Hubinger AM, Wasmuth JC, Schafer G, Behrens G, Mehta SR, Vehreschild JJ, Hoenigl M. Drug Resistance Spread in 6 Metropolitan Regions, Germany, 2001-20181. Emerg Infect Dis. 2020 Oct;26(10):2439-2443. doi: 10.3201/eid2610.191506.
PubMed 32946725Stecher M, Hoenigl M, Eis-Hubinger AM, Lehmann C, Fatkenheuer G, Wasmuth JC, Knops E, Vehreschild JJ, Mehta S, Chaillon A. Hotspots of Transmission Driving the Local Human Immunodeficiency Virus Epidemic in the Cologne-Bonn Region, Germany. Clin Infect Dis. 2019 Apr 24;68(9):1539-1546. doi: 10.1093/cid/ciy744.
PubMed 30169606Stecher M, Chaillon A, Eberle J, Behrens GMN, Eis-Hubinger AM, Lehmann C, Jablonka A, Bogner J, Fatkenheuer G, Spinner CD, Wasmuth JC, Kaiser R, Mehta SR, Vehreschild JJ, Hoenigl M. Molecular Epidemiology of the HIV Epidemic in Three German Metropolitan Regions - Cologne/Bonn, Munich and Hannover, 1999-2016. Sci Rep. 2018 May 1;8(1):6799. doi: 10.1038/s41598-018-25004-8.
PubMed 29717148