Trial record 9 of 42 for:
" September 14, 2011":" October 14, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
RAltegravir Switch STudy: Effects on Endothelial Recovery (RASSTER)
This study is currently recruiting participants.
Verified February 2013 by UMC Utrecht
Sponsor:
UMC Utrecht
Collaborator:
Merck
Information provided by (Responsible Party):
S.F.L. van Lelyveld, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01453933
First received: October 10, 2011
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Endothelial Dysfunction |
Drug: raltegravir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by UMC Utrecht:
Primary Outcome Measures:
- Change in flow mediated dilatation (FMD) of the brachial artery [ Time Frame: week 8, week16 ] [ Designated as safety issue: No ]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)
Secondary Outcome Measures:
- Change in markers of chronic inflammation [ Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16 ] [ Designated as safety issue: No ]
- Change in markers of immune activation [ Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16 ] [ Designated as safety issue: No ]
- Change in markers of endothelial function [ Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16 ] [ Designated as safety issue: No ]
- Changes in plasma HIV-RNA below 50 copies/ml [ Time Frame: Baseline, week 8, week 16 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Raltegravir
At baseline, lopinavir-ritonavir will be switched to raltegravir (cross-over after 8 weeks).
|
Drug: raltegravir
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)
|
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 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.
Objective:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453933
Contacts
| Contact: Steven FL van Lelyveld, MD | s.f.l.vanlelyveld@umcutrecht.nl | |
| Contact: Andy IM Hoepelman, MD, PhD | i.m.hoepelman@umcutrecht.nl |
Locations
| Netherlands | |
| 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 s.f.l.vanlelyveld@umcutrecht.nl | |
| Contact: Andy IM Hoepelman, MD, PhD i.m.hoepelman@umcutrecht.nl | |
| Sub-Investigator: Steven FL van Lelyveld, MD | |
| Principal Investigator: Andy IM Hoepelman, MD, PhD | |
Sponsors and Collaborators
UMC Utrecht
Merck
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | S.F.L. van Lelyveld, principal investigator, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01453933 History of Changes |
| Other Study ID Numbers: | RASSTER2010 |
| Study First Received: | October 10, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by UMC Utrecht:
|
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Lopinavir/ritonavir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lopinavir |
Anti-Infective Agents Ritonavir Anti-Retroviral Agents Therapeutic Uses Pharmacologic Actions HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Antiviral Agents |
ClinicalTrials.gov processed this record on May 19, 2013