2000 HIV Human Functional Genomics Partnership Program

2000 HIV Human Functional Genomics Partnership Program - 2000-HIV study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52894

Enrollment

2000

Registered

2019-07-09

Start date

2019-10-16

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS HIV

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - HIV1 infection - Age >/= 18 - cART >=6 months with an HIV-RNA load 5 year without cART AND - with always HIV-RNA >50-10.000 copies/ml AND - always CD4> 500 cells/uL, OR - on cART, but before start cART >5 year without cART AND - with always HIV-RNA >50-10.000 copies/ml AND - always CD4> 500 cells/uL Non-viremic elite controllers: - HIV-positive > 1 year without cART AND - with >3 consecutive HIV-RNA 12 months AND - stable CD4> 350 cells/uL, OR - on cART, but before start cART > 1 year without cART AND - with >3 consecutive HIV-RNA 12 months AND - stable CD4> 350 cells/uL - No active hepatitis B/C or signs of acute infections

Exclusion criteria

Exclusion criteria: - Active hepatitic B/C or signs of acute infection - Known malignancy - Language barrier that limits effective communication - Pregnancy

Design outcomes

Primary

Measure	Time frame
Primary outcomes: • Metadata: Lifestyle questionnaires, Neuropsychiatric questionnaire • Clinical data: e.g. CD4 nadir, viral load, ART • CVD Clinical events, metabolome, ECG IMT measurement • DNA: Gene polymorphisms at DNA level, epigenetics • Microbiome: Presence of groups of bacteria • Phenotype: Specific populations of circulating cells • Functional data: Cytokine production • Virology Reservoir, resistance • NAFLD Fibroscan/specialized ultrasound Primary study endpoints: • Generate a high quality, robust, cross-omics dataset complementary to clinical and immunological data within well-characterized clinical cohorts of HIV patients. • Conduct systems biology analyses aligned with collaboration objectives, that will result in identifying novel biomarkers and pathways/mechanisms that determine susceptibility to non-AIDS complications such as NAFLD and CVD in PLHIV. • Identify omics-based characteristics and biomarkers associated with extreme HIV phenotypes. • Describe potential relationship of host/immune profiles on efficacy, safety, and tolerability of different standard of care regimens. • Identify the contribution of aging, female gender, or genetic background on host-immune profiles and non-AIDS complications in PLHIV.	—

Measure

Time frame

Primary outcomes: • Metadata: Lifestyle questionnaires, Neuropsychiatric questionnaire • Clinical data: e.g. CD4 nadir, viral load, ART • CVD Clinical events, metabolome, ECG IMT measurement • DNA: Gene polymorphisms at DNA level, epigenetics • Microbiome: Presence of groups of bacteria • Phenotype: Specific populations of circulating cells • Functional data: Cytokine production • Virology Reservoir, resistance • NAFLD Fibroscan/specialized ultrasound Primary study endpoints: • Generate a high quality, robust, cross-omics dataset complementary to clinical and immunological data within well-characterized clinical cohorts of HIV patients. • Conduct systems biology analyses aligned with collaboration objectives, that will result in identifying novel biomarkers and pathways/mechanisms that determine susceptibility to non-AIDS complications such as NAFLD and CVD in PLHIV. • Identify omics-based characteristics and biomarkers associated with extreme HIV phenotypes. • Describe potential relationship of host/immune profiles on efficacy, safety, and tolerability of different standard of care regimens. • Identify the contribution of aging, female gender, or genetic background on host-immune profiles and non-AIDS complications in PLHIV.

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Countries

Netherlands

Outcome results