Identification and characterization of the latent HIV-infected reservoir in long-term anti-retroviral therapy (ART) suppressed patients

Identification and characterization of the latent HIV-infected reservoir in long-term anti-retroviral therapy (ART) suppressed patients - Identification of the latent HIV-reservoir

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43932

Enrollment

Registered

2016-06-16

Start date

2016-11-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

HIV-infection infection with human immunodeficiency virus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The intended participants are eight HIV-infected UMC Utrecht patients and part of the CHEESE cohort. The patients in the CHEESE cohort were among the first HIV patients in the Netherlands on effective ART (1997), and the intended subset of eight patients has previously (2005) donated a large blood draw (METC-04017). At that time-point, after 8 years of effective therapy, HIV DNA could still be detected in these patients. Now, 10 years later, we would like to re-approach these patients to donate a large blood draw, which will allow us to longitudinally assess in more detail if and in which T-cell subsets HIV can reside.

Exclusion criteria

Exclusion criteria: Unability to undergo a large blood draw in the opinion of the treating physician.

Design outcomes

Primary

Measure	Time frame
Aim 1) Identify and quantify the HIV reservoir in T-cell subsets after almost 20 years of effective ART. * Amount of viral DNA in T-cell subsets. * Amount of 2-LTR circles in T-cell subsets. * Amount of intracellular viral RNA in T-cell subsets. * Amount of extracellular viral RNA in plasma. Aim 2) Determine the characteristics of the different cell subsets with respect to immunological markers and viral quasi species. * Sequencing of viral RNA in plasma. * Sequencing of viral DNA in T-cell subsets. * Sequencing of HIV DNA integration sites in T-cell subsets. * Amount of soluble cell-activation markers in plasma. * Amount of cell-activation markers in T-cell subsets and other cells such as CD8+ T-cells, monocytes and NK cells. Aim 3) Determine the reactivation potential of the latently infected T-cell subsets. * Amount of intra- and extracellular viral RNA before and after stimulation of different CD4+ T-cell subsets by anti-latency compounds. * Amount of intra- and extracellular cell activation markers before and after stimulation by anti-latency compounds.	—

Measure

Time frame

Aim 1) Identify and quantify the HIV reservoir in T-cell subsets after almost 20 years of effective ART. * Amount of viral DNA in T-cell subsets. * Amount of 2-LTR circles in T-cell subsets. * Amount of intracellular viral RNA in T-cell subsets. * Amount of extracellular viral RNA in plasma. Aim 2) Determine the characteristics of the different cell subsets with respect to immunological markers and viral quasi species. * Sequencing of viral RNA in plasma. * Sequencing of viral DNA in T-cell subsets. * Sequencing of HIV DNA integration sites in T-cell subsets. * Amount of soluble cell-activation markers in plasma. * Amount of cell-activation markers in T-cell subsets and other cells such as CD8+ T-cells, monocytes and NK cells. Aim 3) Determine the reactivation potential of the latently infected T-cell subsets. * Amount of intra- and extracellular viral RNA before and after stimulation of different CD4+ T-cell subsets by anti-latency compounds. * Amount of intra- and extracellular cell activation markers before and after stimulation by anti-latency compounds.

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Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results