NCT02149004

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
106mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Apr 2015Jan 2035

First Submitted

Initial submission to the registry

May 16, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
19.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

19.8 years

First QC Date

May 16, 2014

Last Update Submit

October 26, 2017

Conditions

Keywords

Human immunodeficiency virus (HIV)PreventionLong-term lifeCureCohort

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 20 years

Secondary Outcomes (1)

  • Incidence of chronic organ failure and malignant diseases in HIV infected patients

    Up to 20 years

Other Outcomes (1)

  • Sustained viral response rate 12 months after discontinuation of ART

    Up to 20 years

Study Arms (9)

Site Bonn

Site Heidelberg

Site Munich

Site Hamburg

Site Hannover

Site Cologne

Site Freiburg

Site Frankfurt

Site Essen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients HIV positive and who are treated in one of the six partner sites

You may qualify if:

  • HIV positive

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

RECRUITING

Related Publications (7)

  • 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.

    PMID: 24081925BACKGROUND
  • Trickey 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.

  • Trickey 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.

  • Mathe 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.

  • Stecher 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.

  • Stecher 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.

  • Stecher 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Liquids, tissue, and pathogens from consenting patients will be stored in a decentral biobank.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jörg Janne Vehreschild, MD

    University Hospital of Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Janne Vehreschild, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 29, 2014

Study Start

April 1, 2015

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2035

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations