Status:
UNKNOWN
RAltegravir Switch STudy: Effects on Endothelial Recovery
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
Endothelial Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 switc...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01453933
Start Date
January 1 2012
End Date
December 1 2014
Last Update
December 18 2013
Active Locations (2)
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1
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands, 1091 AC
2
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX