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RAltegravir Switch STudy: Effects on Endothelial Recovery

NCT ID: NCT01453933

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infection Endothelial Dysfunction

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltegravir

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

Group Type ACTIVE_COMPARATOR

raltegravir

Intervention Type DRUG

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

Lopinavir/ritonavir

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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raltegravir

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

Intervention Type DRUG

Other Intervention Names

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Isentress

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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S.F.L. van Lelyveld

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andy IM Hoepelman, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht, The Netherlands

Steven FL van Lelyveld, MD

Role: STUDY_DIRECTOR

University Medical Center Utrecht, The Netherlands

Locations

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Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Steven FL van Lelyveld, MD

Role: CONTACT

Email: [email protected]

Andy IM Hoepelman, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Guido van den Berk, MD, PhD

Role: primary

Steven FL van Lelyveld, MD

Role: primary

Andy IM Hoepelman, MD, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 29770748 (View on PubMed)

Other Identifiers

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RASSTER2010

Identifier Type: -

Identifier Source: org_study_id