RAltegravir Switch STudy: Effects on Endothelial Recovery (RASSTER)
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|ClinicalTrials.gov Identifier: NCT01453933|
Recruitment Status : Unknown
Verified December 2013 by S.F.L. van Lelyveld, UMC Utrecht.
Recruitment status was: Recruiting
First Posted : October 18, 2011
Last Update Posted : December 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Endothelial Dysfunction||Drug: raltegravir||Phase 4|
Fixed dose combination lopinavir/ritonavir (LPV/r) is a widespread used antiretroviral drug belonging to the class of protease inhibitors (PIs). PIs are associated with an increased risk of myocardial infarction. However, data is available suggesting increased levels of plasma lipids are not the sole explanation for this observation. Treatment with LPV/r might lead to a decrease of endothelial function as well, thus explaining the increased risk of myocardial infarction besides increased plasma lipids. Raltegravir is a registered antiretroviral drug with no known cardiovascular side effects. We hypothesize that switching LPV/r to raltegravir in HIV-infected patients with suppressed plasma viral load (<50 copies/ml) will lead to an improvement of endothelial function.
- First, to assess the effect of the switch of lopinavir/ritonavir to raltegravir on endothelial function.
- Second, to assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on plasma HIV-RNA below the cut-off of 50 copies/ml.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV, Randomized, Open Label, Crossover, Intervention Trial to Investigate the Effect of the Switch of Lopinavir/Ritonavir to Raltegravir on Endothelial Function, Chronic Inflammation, Immune Activation and HIV Replication <50 Copies/ml|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||December 2014|
Active Comparator: Raltegravir
At baseline, lopinavir-ritonavir will be switched to raltegravir (cross-over after 8 weeks).
Switch of lopinavir/ritonavir to raltegravir 400 mg BID (duration 8 weeks)
Other Name: Isentress
No Intervention: Lopinavir/ritonavir
Subjects will continue lopinavir/ritonavir (cross-over after 8 weeks)
- Change in flow mediated dilatation (FMD) of the brachial artery [ Time Frame: week 8, week16 ]Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of raltegravir treatment as compared to the control group (treatment with lopinavir/ritonavir)
- Change in markers of chronic inflammation [ Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16 ]
- Change in markers of immune activation [ Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16 ]
- Change in markers of endothelial function [ Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16 ]
- Changes in plasma HIV-RNA below 50 copies/ml [ Time Frame: Baseline, week 8, week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453933
|Contact: Steven FL van Lelyveld, MDfirstname.lastname@example.org|
|Contact: Andy IM Hoepelman, MD, PhDemail@example.com|
|Onze Lieve Vrouwe Gasthuis||Recruiting|
|Amsterdam, Noord Holland, Netherlands, 1091 AC|
|Contact: Guido van den Berk, MD, PhD G.E.L.vandenBerk@olvg.nl|
|University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584CX|
|Contact: Steven FL van Lelyveld, MD firstname.lastname@example.org|
|Contact: Andy IM Hoepelman, MD, PhD email@example.com|
|Sub-Investigator: Steven FL van Lelyveld, MD|
|Principal Investigator: Andy IM Hoepelman, MD, PhD|
|Principal Investigator:||Andy IM Hoepelman, MD||University Medical Center Utrecht, The Netherlands|
|Study Director:||Steven FL van Lelyveld, MD||University Medical Center Utrecht, The Netherlands|