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RAltegravir Switch STudy: Effects on Endothelial Recovery

NCT01453933 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-12-18

No results posted yet for this 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.

Conditions

  • HIV Infection
  • Endothelial Dysfunction

Interventions

DRUG

raltegravir

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

Sponsors & Collaborators

Principal Investigators

  • Andy IM Hoepelman, MD · University Medical Center Utrecht, The Netherlands

  • Steven FL van Lelyveld, MD · University Medical Center Utrecht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453933 on ClinicalTrials.gov