Switch from a NNRTI or PI-based regimen to a RAltegravir-based regimen in virologically suppressed HIV-infected patients: effects on Platelet reactivity, platelet-monocyte aggregation and the Inflammatory anD thrombotic state of monocytes

Switch from a NNRTI or PI-based regimen to a RAltegravir-based regimen in virologically suppressed HIV-infected patients: effects on Platelet reactivity, platelet-monocyte aggregation and the Inflammatory anD thrombotic state of monocytes - RAPID-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42115

Enrollment

Registered

2015-01-20

Start date

2015-03-23

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

human immunodeficiency virus (HIV)

Interventions

Participants will be randomized (1:1) to continue the same ART regimen (*Continuation group*) or to switch their NNRTI or PI to raltegravir (*Switch group*) during 10 weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Documented HIV-infection •Age >= 18 years •On stable antiretroviral therapy (ART) for >= 6 months at screening •Undetectable plasma HIV viral load ( 300 cells/mm3 at last measurement •Current ART regimen at screening consisting of a backbone of two NRTI*s (either TDF/FTC or ABC/3TC) with either a NNRTI (EFV or RPV) or a boosted PI (DRV/r, ATZ/r or LPV/r) and on this regimen for > 3 months •If female and of childbearing potential using effective birth control methods

Exclusion criteria

Exclusion criteria: •Use of platelet function inhibitors, such as aspirin and ADP receptor antagonists •Known hypersensitivity to raltegravir or any other component of the formulation •Using any concomitant therapy disallowed as per SPC for the study drug •Signs of symptoms of an active (opportunistic) infection other than HIV •Active hepatitis B or C •Estimated glomerular filtration rate (by MDRD)

Design outcomes

Primary

Measure	Time frame
1. Platelet reactivity: platelet expression of the platelet activation marker CD62P (P-selectin) and activated fibrinogen receptor (aIIbβ3) upon stimulation with different platelet agonists. 2. Platelet-leukocyte aggregates (eg. PMA). 3. Proportion of CD14+CD16 ++(bright) monocytes compared to CD14+CD16- and activation state of monocytes (CD11b expression) and lymphocytes (CD38+ HLA-DR+ CD8+ T cells). 4. Soluble (plasma) markers of platelet and monocyte activation.	—

Measure

Time frame

1. Platelet reactivity: platelet expression of the platelet activation marker CD62P (P-selectin) and activated fibrinogen receptor (aIIbβ3) upon stimulation with different platelet agonists. 2. Platelet-leukocyte aggregates (eg. PMA). 3. Proportion of CD14+CD16 ++(bright) monocytes compared to CD14+CD16- and activation state of monocytes (CD11b expression) and lymphocytes (CD38+ HLA-DR+ CD8+ T cells). 4. Soluble (plasma) markers of platelet and monocyte activation.

—

Secondary

Measure	Time frame
Investigate whether switch to raltegravir is associated with: a) reduced activation status of monocytes and of CD4 and CD8 lymphocytes b) reduced expression of CCR5 on monocytes and CD4+ T-lymphocytes c) reduced plasma levels of inflammatory markers (eg. hs-CRP, several cytokines) d) epigenetic changes (eg. Histone methylation) e) altered IL-32 expression and splicing	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)