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

Phase 4

Completed

• Conditions: hart- en vaatziekten; HIV; 10047438; 10003216

• Registration Number: NL-OMON39957
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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 <50 copies/ml) of 6 months
-Subjects will not have a history of virological failure on antiretroviral therapy
-Results of previous resistance testing allowing replacement of lopinavir-ritonavir or atazanavir/ritonavir by raltegravir
-CD4+ cell count > 200 cells/µL
-Signed informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks<br /><br>of raltegravir treatment (compared to treatment with protease inhibitors). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Change in endothelial function measured by EndoPAT<br /><br>-change in markers of endothelial function<br /><br>-change in markers of chronic inflammation<br /><br>-change in markers of immune activation<br /><br>-change in plasma HIV-RNA below 50 copies/ml </p><br>