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Status unknownNCT01453933RASSTERUpdated Dec 18, 2013

RAltegravir Switch STudy: Effects on Endothelial Recovery

A Phase 4 interventional study of raltegravir in HIV Infection and Endothelial Dysfunction, sponsored by UMC Utrecht. Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.

Sponsored by UMC Utrecht · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • HIV Infection
  • Endothelial Dysfunction

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Keywords

  • Anti-HIV Agents
  • Anti-Retroviral Agents
  • Antiviral Agents
  • Anti-Infective Agents
  • Lopinavir/ritonavir
03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's planned enrollment of 24 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 363 studies on the registry; 81 are open to participants now.

Browse UMC Utrecht studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Raltegravir

    At baseline, lopinavir-ritonavir will be switched to raltegravir (cross-over after 8 weeks).

    Drug: raltegravir

  • No intervention
    Lopinavir/ritonavir

    Subjects will continue lopinavir/ritonavir (cross-over after 8 weeks)

Interventions

  • Drugraltegravir

    Switch of lopinavir/ritonavir to raltegravir 400 mg BID (duration 8 weeks)

    Also known as: Isentress

06

What researchers measure

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)

    Time frame: week 8, week16

Secondary outcomes

  1. Change in markers of chronic inflammation

    Time frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16

  2. Change in markers of immune activation

    Time frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16

  3. Change in markers of endothelial function

    Time frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16

  4. Changes in plasma HIV-RNA below 50 copies/ml

    Time frame: Baseline, week 8, week 16

07

Study locations

2 of 2 sites recruiting
  • Onze Lieve Vrouwe Gasthuis
    Amsterdam, North Holland 1091 AC, Netherlands
    Recruiting
  • University Medical Center Utrecht
    Utrecht, 3584CX, Netherlands
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29770748 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Oct 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2011
First posted
Oct 18, 2011
Start
Jan 2012
Primary completionEst.
Oct 2014
CompletionEst.
Dec 2014
Last update
Dec 18, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01453933
Lead sponsor
UMC Utrecht
Collaborators
Merck Sharp & Dohme LLC
Responsible party
S.F.L. van Lelyveld (principal investigator, UMC Utrecht) — Principal investigator
First posted
Oct 18, 2011
Start date
Jan 2012
Primary completion
Oct 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Dec 18, 2013

Study contacts

Steven FL van Lelyveld, MD
Contact
s.f.l.vanlelyveld@umcutrecht.nl
Andy IM Hoepelman, MD, PhD
Contact
i.m.hoepelman@umcutrecht.nl
Andy IM Hoepelman, MD
principal investigator · University Medical Center Utrecht, The Netherlands
Steven FL van Lelyveld, MD
study director · University Medical Center Utrecht, The Netherlands

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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