2000 HIV Human Functional Genomics Partnership Program (2000HIV)
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ClinicalTrials.gov Identifier: NCT03994835 |
Recruitment Status :
Active, not recruiting
First Posted : June 21, 2019
Last Update Posted : August 15, 2022
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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.
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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
- Collection of metadata using questionnaires and patient medical records
- Asses co-pathology (CVD and NAFLD)
- Blood will be drawn for genetic, epigenetic, proteomic, metabolomic, microbiome, immunological, and virological analyses
After 2 years follow-up
- Collection of metadata using questionnaires and patient medical records
- Asses co-pathology (CVD and NAFLD)
- Blood samples will be collected for biomarker and infection/inflammation parameter analysis
Condition or disease |
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HIV Infections |

Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 1909 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
Official Title: | 2000 HIV Human Functional Genomics Partnership Program |
Actual Study Start Date : | October 16, 2019 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | January 31, 2026 |
- Change in liver fibrosis [ Time Frame: Change: 2-year value - baseline value ]Change in liver fibrosis measurement by FibroScan (method by Echosens)
- Change in liver steatosis [ Time Frame: Change: 2-year value - baseline value ]Change in liver steatosis measurement by FibroScan (method by Echosens) and liver ultrasound (method developed by Radboudumc)
- Change in cardiovascular risk score (Framingham score) [ Time Frame: Change: 2-year value - baseline value ]Framingham score
- Change in cardiovascular risk score (D:A:D score) [ Time Frame: Change: 2-year value - baseline value ]D:A:D score
- Number and type of cardiovascular events [ Time Frame: Number of events over 2 years between baseline and 2-year time point ]
Recoring of cadiovascular diseases from patient file:
- Stroke/ TIA
- Angina pectoris
- Myocardial infarction
- Claudicatio intermittens
- Venous thrombo-embolism
- Other …
- Genetic data [ Time Frame: At baseline only ]Genome-wide genotype data including >8 million SNPs per individual
- Colonizing microbiome profile [ Time Frame: At baseline only ]Colonizing microbiome profile will be generated from stool and saliva samples
- Transcriptomics [ Time Frame: At baseline only ]RNA-sequencing will be performed in PBMCs
- Quantification of a wide range of metabolites [ Time Frame: At baseline only ]Metabolomics analysis by multiplex immunoassays will be performed in plasma or serum
- Cytokine production of PBMCs in ex vivo stimulation experiments [ Time Frame: At baseline only ]Ex vivo cytokine responses of isolated PBMCs to a range of stimuli (TLR ligands, killed pathogens and viral antigen stimuli)
- Immune phenotyping [ Time Frame: At baseline only ]Extensive phenotyping of circulating immune cells by flow cytometry analysis
- Change in ECG [ Time Frame: ECG paramater changes between baseline and 2-year time visit ]Standardized signs of myocardial infarction with MEANS ECG software, as extensively described elsewehere. In addition, we will look at the full list of ECG output measurements as described elsewhere*: in brief, MEANS reliably provides output on interpretation of the ECG rhythm and morphology. The morphological interpretation consists of separate analyses of the P wave, QRS complex, and ST-T segment. Reference: Van den Berg ME, Rijnbeek PR, Niemeijer MN, et al. Normal values of corrected heart-rate variability in 10-second electrocardiograms for all ages. Front Physiol. 2018;9:424
- Intima-media thickness [ Time Frame: At baseline only ]Ultrasound measurement of intima-media thickness in the carotid artery as a measure for atherosclerosis and cardiovasculr disease risk.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV-infected,
- aged ≥18 years,
- on cART ≥6 months with an HIV-RNA load <200 copies/mL, *Apart from the above-mentioned subjects, elite controllers that are not on cART, are also eligible.
Exclusion Criteria:
- No informed consent
- Insufficient communication because of language or other problems
- Active hepatitis B/C or signs of acute infections
- Pregnancy

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): NCT03994835
Netherlands | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1091AC | |
Radboudumc | |
Nijmegen, Netherlands, 6525GA | |
Erasmus MC | |
Rotterdam, Netherlands, 3015GD | |
Elisabeth Twee-Steden ziekenhuis | |
Tilburg, Netherlands, 5042AD |
Principal Investigator: | Quirijn de Mast, Dr. | Radboud University Medical Center | |
Principal Investigator: | Annelies Verbon, Prof. | Erasmus Medical Center | |
Principal Investigator: | Willem Blok, Dr. | Onze Lieve Vrouwe Gasthuis | |
Principal Investigator: | Marvin Berrevoets, Drs. | Elisabeth Twee-Steden ziekenhuis |
Responsible Party: | Radboud University Medical Center |
ClinicalTrials.gov Identifier: | NCT03994835 |
Other Study ID Numbers: |
NL.68056.091.18 |
First Posted: | June 21, 2019 Key Record Dates |
Last Update Posted: | August 15, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV Non-alcoholic fatty liver disease Cardiovascular disease Omics data Inflammation |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections |
Retroviridae Infections RNA Virus Infections Virus Diseases Genital Diseases Urogenital Diseases Immunologic Deficiency Syndromes Immune System Diseases |