Endothelial DysfunctionPhase 4MASTERNCT01389063
Maraviroc Abacavir STudy - Effect on Endothelial Recovery
A Phase 4 study testing Maraviroc in people with Endothelial Dysfunction, run by S.F.L. van Lelyveld at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Breastfeeding
- Allergy for peanuts or soya
- Hypersensitivity for maraviroc
- Treatment of underlying malignancy
- Acute infection in the preceding 30 days
Show all 9Show fewer
- Renal insufficiency requiring hemodialysis
- Acute or decompensated chronic hepatitis
- Modification of antiretroviral regimen in the previous 3 months
Trial locations and contacts
1 site in 1 country.
Steven FL van Lelyveld, MD contact
A IM Hoepelman, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584CX
Steven FL van Lelyveld, MD, s.f.l.vanlelyveld@umcutrecht.nl
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Endothelial Dysfunction
- Being tested
- Maraviroc
- Keywords
- endothelial function, CCR5 receptor, Maraviroc, Abacavir, Flow Mediated Dilatation, EndoPAT
- Medical subject headings
- Diabetes Mellitus, Insulin-Dependent, 22
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Celsentri
HAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | HAART of subjects in arm A will be intensified with maraviroc during week 1-8. Receives: Drug: Maraviroc |
| Arm B | Active comparator | HAART of subjects enrolled in arm B will be intensified with maraviroc during week 9-16 Receives: Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of maraviroc treatment as compared to the control group
Measured: After 8 weeks of treatment (cross-over)
Secondary outcomes (5)
Change in markers of chronic inflammation
Measured: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Change in markers of immune activation
Measured: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Change in markers of endothelial function
Measured: Baseline, week 2, week 4, week 8, week 10, week 12 and week 16
Changes in plasma HIV-RNA below 50 copies/ml
Measured: Baseline, week 8, week 16
Change in endothelial function measured by EndoPAT
Measured: baseline, week 8, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.F.L. van Lelyveld
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, S.F.L. van Lelyveld, UMC Utrecht
- Investigators
- A IM Hoepelman, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389063
- Sponsor's protocol ID
- MASTER2010
- Acronym
- MASTER
- Status last verified
- Dec 2013
- First submitted
- 5 Jul 2011
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27300170
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maraviroc Abacavir STudy - Effect on Endothelial Recovery
- ClinicalTrials.gov ID
- NCT01389063
- Acronym / sponsor ID
- MASTER / MASTER2010
- Conditions
- Endothelial Dysfunction
- Keywords
- endothelial function, CCR5 receptor, Maraviroc, Abacavir, Flow Mediated Dilatation, EndoPAT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- S.F.L. van LelyveldUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: MaravirocHAART of subjects in arm A will be intensified with maraviroc during week 1-8. |
| Arm B | Active comparator | Drug: MaravirocHAART of subjects enrolled in arm B will be intensified with maraviroc during week 9-16 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Breastfeeding
- Allergy for peanuts or soya
- Hypersensitivity for maraviroc
- Treatment of underlying malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaravirocAlso: CelsentriHAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8. | Drug | Arm A, Arm B |
Primary outcome
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)
5 secondary outcomes
Change in markers of chronic inflammation
Time frame: 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
Change in markers of endothelial function
Time frame: 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
Change in endothelial function measured by EndoPAT
Time frame: baseline, week 8, week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Derived from this study: PubMed 27300170Krikke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven FL van Lelyveld, MD contact
A IM Hoepelman, MD, PhD contact
A IM Hoepelman, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maraviroc in people with Endothelial Dysfunction, run by S.F.L. van Lelyveld at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven FL van Lelyveld, MD (s.f.l.vanlelyveld@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.