A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of protease inhibitors to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml

A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of protease inhibitors to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml - RASSTER

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39957

Enrollment

Registered

2011-11-08

Start date

2012-02-16

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

hart- en vaatziekten HIV

Interventions

Randomisation into two arms: A and B. In arm A, LPV/r or ATZ/r will be switched to raltegravir, while study subjects in arm B will continue their LPV/r or ATZ/r-containing regimen. After 8 weeks, cr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Age >= 18 years -HIV-1 infection -Treatment with antiretroviral regimen containing lopinavir/ritonavir or atazanavir/ritonavir for at least the previous 3 months -No other protease inhibitors besides lopinavir-ritonavir or atazanavir/ritonavir in antiretroviral regimen -Subjects must have a minimum period of viral suppression (plasma HIV-RNA 200 cells/µL -Signed informed consent

Exclusion criteria

Exclusion criteria: -Pregnancy -Breastfeeding -Raltegravir hypersensitivity -Treatment of underlying malignancy -Renal insufficiency requiring dialysis -Acute or decompensated chronic hepatitis (Child-Pugh score C) -Modification of antiretroviral regimen in the previous 3 months

Design outcomes

Primary

Measure	Time frame
Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of raltegravir treatment (compared to treatment with protease inhibitors).	—

Secondary

Measure	Time frame
-Change in endothelial function measured by EndoPAT -change in markers of endothelial function -change in markers of chronic inflammation -change in markers of immune activation -change in plasma HIV-RNA below 50 copies/ml	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)