MedDataX Logo

Maraviroc Abacavir STudy - Effect on Endothelial Recovery

NCT ID: NCT01389063

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endothelial Dysfunction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

endothelial function CCR5 receptor Maraviroc Abacavir Flow Mediated Dilatation EndoPAT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

HAART of subjects in arm A will be intensified with maraviroc during week 1-8.

Group Type ACTIVE_COMPARATOR

Maraviroc

Intervention Type DRUG

HAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8.

Arm B

HAART of subjects enrolled in arm B will be intensified with maraviroc during week 9-16

Group Type ACTIVE_COMPARATOR

Maraviroc

Intervention Type DRUG

HAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maraviroc

HAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Celsentri

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

S.F.L. van Lelyveld

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

S.F.L. van Lelyveld

Coordinating investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

A IM Hoepelman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Steven FL van Lelyveld, MD

Role: CONTACT

Email: [email protected]

A IM Hoepelman, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Steven FL van Lelyveld, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Krikke M, Tesselaar K, Arends JE, Drylewicz J, Otto SA, van Lelyveld SF, Visseren FJ, Hoepelman AI. Maraviroc Intensification Improves Endothelial Function in Abacavir-Treated Patients, an Open-Label Randomized Cross-Over Pilot Study. Infect Dis Ther. 2016 Sep;5(3):389-404. doi: 10.1007/s40121-016-0115-0. Epub 2016 Jun 14.

Reference Type DERIVED
PMID: 27300170 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MASTER2010

Identifier Type: -

Identifier Source: org_study_id