RAltegravir Switch STudy: Effects on Endothelial Recovery
RASSTER
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
1 other identifier
interventional
24
1 country
2
Brief Summary
Treatment with HIV-infection with protease inhibitors is associated with high blood lipids and higher chance for cardiovascular complications. The RASSTER study aims to investigate the effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel wall function and inflammation,and activation of the immune system. we hypothesize that with this intervention these parameters will improve. Since decreased vessel wall function and inflammation are initial steps in the process of atherosclerosis, it is important to know this data when treating HIV-infected patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2012
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
October 18, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 18, 2013
December 1, 2013
2.8 years
October 10, 2011
December 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in flow mediated dilatation (FMD) of the brachial artery
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)
week 8, week16
Secondary Outcomes (4)
Change in markers of chronic inflammation
Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Change in markers of immune activation
Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Change in markers of endothelial function
Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Changes in plasma HIV-RNA below 50 copies/ml
Baseline, week 8, week 16
Study Arms (2)
Raltegravir
ACTIVE COMPARATORAt baseline, lopinavir-ritonavir will be switched to raltegravir (cross-over after 8 weeks).
Lopinavir/ritonavir
NO INTERVENTIONSubjects will continue lopinavir/ritonavir (cross-over after 8 weeks)
Interventions
Switch of lopinavir/ritonavir to raltegravir 400 mg BID (duration 8 weeks)
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- HIV-1 infection
- Treatment with antiretroviral regimen containing lopinavir/ritonavir for at least the previous 3 months
- No other protease inhibitors besides lopinavir/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 by raltegravir
- CD4+ cell count \> 200 cells/µL
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091 AC, Netherlands
University Medical Center Utrecht
Utrecht, 3584CX, Netherlands
Related Publications (1)
Krikke M, Tesselaar K, van den Berk GEL, Otto SA, Freriks LH, van Lelyveld SFL, Visseren FJL, Hoepelman AIM, Arends JE. The effect of switching protease inhibitors to raltegravir on endothelial function, in HIV-infected patients. HIV Clin Trials. 2018 Apr;19(2):75-83. doi: 10.1080/15284336.2018.1455366.
PMID: 29770748DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 10, 2011
First Posted
October 18, 2011
Study Start
January 1, 2012
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
December 18, 2013
Record last verified: 2013-12