Maraviroc Abacavir STudy - Effect on Endothelial Recovery (MASTER)

December 17, 2013 updated by: S.F.L. van Lelyveld

HIV infected patients treated with abacavir might have a higher risk for the occurrence of cardiovascular events. At time of writing of this protocol the underlying mechanism is not yet elucidated, however some studies find impaired endothelial function and elevated markers of chronic inflammation in these patients,suggesting a higher lever of chronic inflammation. Recently maraviroc (Celsentri®), a CCR5-receptor antagonist, became available for treatment of patients infected with HIV-1.

Improvement of endothelial function may be a potential beneficial side effect of treatment with maraviroc, due to the potential reduction of immune activation and chronic inflammation as a result of blocking the CCR5-coreceptor. Moreover, treatment intensification of HAART with maraviroc in patients with suppressed plasma HIV_RNA may decrease plasma HIVRNA below the cut-off of 50 copies/ml as well.

The investigators hypothesize that maraviroc intensification therapy in patients on an abacavir-containing regimen will improve endothelial function.

The objectives of this study are: First, to assess the effect of addition of maraviroc to an abacavir-containing regimen on endothelial function; second, to assess the effect of this intervention on markers of immune activation and chronic inflammation, and on plasma HIV-RNA below 50 copies/ml.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The MASTER study is a phase IV, randomized, open label, cross-over, intervention study. Study subjects who are on stable abacavir-containing regimen will be randomized into two arms. In arm A maraviroc will be added to their regimen at baseline, while study subjects in arm B will continue their abacavir-containing regimen. After 8 weeks, cross-over of the study arms will be performed. Subjects in arm A will then stop maraviroc, while in subjects in arm B maraviroc will be added to their regimen (for 8 weeks again). The total duration of the study will be 16 weeks.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years
  • HIV-1 infection
  • Treatment with antiretroviral regimen containing abacavir for at least the previous 3 months
  • Undetectable plasma HIV RNA (50 cp/ml) for at least 6 months (one 'blip' allowed, which is defined as a detectable plasma HIV-RNA level between 50 and 400 copies/ml, preceded and followed by undetectable (<50 copies/ml) plasma HIV-RNA measurements)
  • CD4+ cell count > 200 cells/μL
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Allergy for peanuts or soya
  • Hypersensitivity for maraviroc
  • Treatment of underlying malignancy
  • Acute infection in the preceding 30 days
  • Renal insufficiency requiring hemodialysis
  • Acute or decompensated chronic hepatitis
  • Modification of antiretroviral regimen in the previous 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
HAART of subjects in arm A will be intensified with maraviroc during week 1-8.
Drug: Maraviroc
HAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8.
Other Names:
  • Celsentri
Active Comparator: Arm B
HAART of subjects enrolled in arm B will be intensified with maraviroc during week 9-16
Drug: Maraviroc
HAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8.
Other Names:
  • Celsentri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of maraviroc treatment as compared to the control group
Time Frame: After 8 weeks of treatment (cross-over)
After 8 weeks of treatment (cross-over)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in markers of chronic inflammation
Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Change in markers of immune activation
Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Change in markers of endothelial function
Time Frame: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Changes in plasma HIV-RNA below 50 copies/ml
Time Frame: Baseline, week 8, week 16
Baseline, week 8, week 16
Change in endothelial function measured by EndoPAT
Time Frame: baseline, week 8, week 16
baseline, week 8, week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.F.L. van Lelyveld

Investigators

  • Principal Investigator: A IM Hoepelman, MD, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 7, 2011

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MASTER2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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