2000 HIV Human Functional Genomics Partnership Program

Summary

Background Chronic HIV infection leads to a dysregulated immune system, even when full viral suppression is achieved. HIV causes persistent immune activation, relating to an array of common non-AIDS-related diseases such as cardiovascular disease (CVD) and non-alcoholic fatty liver disease (NAFLD). On the other hand, accelerated ageing of the immune system hinders effective immunity against infectious diseases and cancer. Likewise, this derailed inflammatory balance creates a niche for persistent viral replication and reservoir, and prevents cure or functional cure. Mechanisms behind this phenomenon are poorly understood. Inclusion of a larger cohort of HIV-infected patients allows for a more precise assessment of the factors underlying the immune dysregulation.

Primary Objectives

* Identify a set of candidate biomarkers that correlate with particular non-AIDS-related comorbidities
* Unravel biological processes associated with extreme HIV clinical phenotypes.
* Find therapeutic targets to identify novel assets or for repurposing of clinical phase assets from other disease areas for HIV.

Secondary Objectives

* Evaluate potential relationship of host/immune profiles on efficacy, safety, and tolerability of standard care regimens.
* Evaluate the contribution of age, sex, and genetics in host-immune profiles that are:

* distinct to HIV infection relative to controls in other cohorts;
* associated with non-AIDS-related comorbidities in HIV infection relative to non-HIV chronic disease.

Study design 2000 HIV patients will be included in the cohort. The investigators estimate a 2-year inclusion and 2-year follow-up period and will strive for the inclusion of several clinical phenotypes and classical risk group patients. Patients will be recruited from four Dutch HIV treatment centers.

At inclusion

1. Collection of metadata using questionnaires and patient medical records
2. Asses co-pathology (CVD and NAFLD)
3. Blood will be drawn for genetic, epigenetic, proteomic, metabolomic, microbiome, immunological, and virological analyses

After 2 years follow-up

1. Collection of metadata using questionnaires and patient medical records
2. Asses co-pathology (CVD and NAFLD)
3. Blood samples will be collected for biomarker and infection/inflammation parameter analysis

Conditions

• HIV Infections

Sponsors & Collaborators

• ViiV Healthcare

  collaborator INDUSTRY

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Onze Lieve Vrouwe Gasthuis

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Quirijn de Mast, Dr. · Radboud University Medical Center

• Annelies Verbon, Prof. · Erasmus Medical Center

• Willem Blok, Dr. · Onze Lieve Vrouwe Gasthuis

• Marvin Berrevoets, Drs. · Elisabeth Twee-Steden ziekenhuis

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-16

Primary Completion

2023-07-27

Completion

2023-07-28

Countries

• Netherlands

Study Locations