HIV InfectionsPhase 4MIRSNCT00875368
Maraviroc Immune Recovery Study
A Phase 4 study testing maraviroc in people with HIV Infections, run by S.F.L. van Lelyveld at 10 sites in Netherlands.
Trial summary
Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals of antiretroviral therapy in HIV, which is achieved by means of virological suppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- maraviroc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 10 sitesNetherlands
- Study dates
- Feb 2009to Aug 2012
- 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 or older
- HAART with a maximal treatment interruption of two weeks
- viral suppression (< 50 copies/ml) for 6 months
- And either:
- CD4+ count < 200 cells/microliter after minimal one year of treatment with HAART (study group one) OR
- a CD4+ cell count between 200 and 350 cells/microliter after minimal two years of treatment with HAART (study group two)
Who cannot join
- HAART consisting of a combination of tenofovir and didanosine
- Active infection for which antimicrobial treatment
- Acute hepatitis B or C
- Chronic hepatitis B or C for which treatment with (peg)interferon and/or ribavirin (Note: patients with untreated chronic hepatitis B or C can be included)
- Immunosuppressive medication
- Radiotherapy or chemotherapy in the past 2 years
Show all 10Show fewer
- Pregnancy or breastfeeding an infant
- Subjects with known hypersensitivity to maraviroc or to peanuts, or any of its excipients or dyes as follows:
- Excipients from tablet: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate.
- Film-coat: [Opadry II Blue (85G20583) contains FD\&C blue #2 aluminium lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
Academisch Medisch Centrum (AMC)
Amsterdam, 1105AZ
Slotervaartziekenhuis
Amsterdam
Rijnstate Hospital
Arnhem
Kennemer Gasthuis
Haarlem
Leids Universitair Medisch Centrum (LUMC)
Leiden
Erasmus MC
Rotterdam, 3015GJ
Maasstad Ziekenhuis
Rotterdam
Sint Elisabeth Ziekenhuis
Tilburg
Ùniversity Medical Center Utrecht
Utrecht, 3584CX
About this study
Official title: Maraviroc Immune Recovery Study, A Multicenter, Randomized, Placebo-controlled, Exploratory Mechanistic Study Into the Role of Maraviroc on Immune Recovery
Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals of antiretroviral therapy in HIV, which is achieved by means of virological suppression. A certain group of patients, the so called "immunologic non responders", fail to reach an acceptable CD4 cell increase despite an adequate virologic response on antiretroviral treatment. Recently a new antiretroviral agent, maraviroc (Celsentry®), is registered for the treatment of patients infected with CCR5 tropic HIV-1 virus. However, data is available suggesting that treatment with maraviroc leads to immune recovery (increase in CD4 cells) in patients who are infected with dual/mixed tropic HIV-1 virus, in the absence of a virologic response. This suggests an alternative mechanism for immune recovery, which could be especially beneficial for this group of patients.
Hypothesis: Maraviroc, by a yet unknown mechanism, stimulates immune recovery by increasing CD4+ cell count.
Read more
Objective: The primary objective is to confirm the hypothesis that maraviroc stimulates immune recovery; the secondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.
Study design: multicentre, randomized, placebo-controlled, double blind, exploratory mechanistic study.
Study population: HIV-1 infected patients 18 years or older, who meet the inclusion criteria.
Intervention: One group receives maraviroc (dose dependent on co-medication), the other group placebo.
Main study parameters/endpoints: A 30% increase in CD4 cell rise in the treatment group (compared with placebo).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- In the treatment group subjects will start with a registered antiretroviral agent (maraviroc).
- During the treatment year patients will perform several study visits, probably three more compared with regular visits on the outpatient clinic.
- Each visit, blood will be drawn by venepuncture for immunologic and virologic investigations (see flow chart).
- Conditions
- HIV Infections
- Being tested
- maraviroc, Placebo
- Keywords
- HIV-1, HAART, CD4 cell, Immunologic non-responders, Immunology, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maravirocDrug
Also called Celsentri, Celsentry
maraviroc dose dependent on co-medication
PlaceboDrug
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Active comparator | Not described Receives: Drug: maraviroc |
| Placebo | Placebo comparator | Placebo drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% increase in CD4+ cell count after 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionAug 2012
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 HIV InfectionsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.F.L. van Lelyveld
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Leiden University Medical Center, Onze Lieve Vrouwe Gasthuis, Slotervaart Hospital, Rijnstate Hospital, Pfizer
- Responsible party
- Sponsor-investigator, S.F.L. van Lelyveld, UMC Utrecht
- Investigators
- Andy IM Hoepelman, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875368
- Sponsor's protocol ID
- 08-283
- Acronym
- MIRS
- Status last verified
- Sep 2013
- First submitted
- 2 Apr 2009
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Lelyveld SF, Drylewicz J, Krikke M, Veel EM, Otto SA, Richter C, Soetekouw R, Prins JM, Brinkman K, Mulder JW, Kroon F, Middel A, Symons J, Wensing AM, Nijhuis M, Borghans JA, Tesselaar K, Hoepelman AI; MIRS study group. Maraviroc Intensification of cART in Patients with Suboptimal Immunological Recovery: A 48-Week, Placebo-Controlled Randomized Trial. PLoS One. 2015 Jul 24;10(7):e0132430. doi: 10.1371/journal.pone.0132430. eCollection 2015.
PubMed 26208341
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maraviroc Immune Recovery Study, A Multicenter, Randomized, Placebo-controlled, Exploratory Mechanistic Study Into the Role of Maraviroc on Immune Recovery
- ClinicalTrials.gov ID
- NCT00875368
- Acronym / sponsor ID
- MIRS / 08-283
- Conditions
- HIV Infections
- Keywords
- HIV-1, HAART, CD4 cell, Immunologic non-responders, Immunology, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- S.F.L. van LelyveldUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Leiden University Medical Center, Onze Lieve Vrouwe Gasthuis, Slotervaart Hospital, Rijnstate Hospital, Pfizer
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Apr 2009 (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.
Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals of antiretroviral therapy in HIV, which is achieved by means of virological suppression. A certain group of patients, the so called "immunologic non responders", fail to reach an acceptable CD4 cell increase despite an adequate virologic response on antiretroviral treatment. Recently a new antiretroviral agent, maraviroc (Celsentry®), is registered for the treatment of patients infected with CCR5 tropic HIV-1 virus. However, data is available suggesting that treatment with maraviroc leads to immune recovery (increase in CD4 cells) in patients who are infected with dual/mixed tropic HIV-1 virus, in the absence of a virologic response. This suggests an alternative mechanism for immune recovery, which could be especially beneficial for this group of patients.
Hypothesis: Maraviroc, by a yet unknown mechanism, stimulates immune recovery by increasing CD4+ cell count.
Objective: The primary objective is to confirm the hypothesis that maraviroc stimulates immune recovery; the secondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.
Study design: multicentre, randomized, placebo-controlled, double blind, exploratory mechanistic study.
Study population: HIV-1 infected patients 18 years or older, who meet the inclusion criteria.
Intervention: One group receives maraviroc (dose dependent on co-medication), the other group placebo.
Main study parameters/endpoints: A 30% increase in CD4 cell rise in the treatment group (compared with placebo).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- In the treatment group subjects will start with a registered antiretroviral agent (maraviroc).
- During the treatment year patients will perform several study visits, probably three more compared with regular visits on the outpatient clinic.
- Each visit, blood will be drawn by venepuncture for immunologic and virologic investigations (see flow chart).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | Active comparator | Drug: maraviroc |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo drug |
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 or older
- HAART with a maximal treatment interruption of two weeks
- viral suppression (< 50 copies/ml) for 6 months
- And either:
Key exclusion criteria (10 listed)
- HAART consisting of a combination of tenofovir and didanosine
- Active infection for which antimicrobial treatment
- Acute hepatitis B or C
- Chronic hepatitis B or C for which treatment with (peg)interferon and/or ribavirin (Note: patients with untreated chronic hepatitis B or C can be included)
- Immunosuppressive medication
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: Celsentri, Celsentrymaraviroc dose dependent on co-medication | Drug | Maraviroc |
| PlaceboPlacebo drug | Drug | Placebo |
Primary outcome
30% increase in CD4+ cell count after 48 weeks
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Derived from this study: PubMed 26208341van Lelyveld SF, Drylewicz J, Krikke M, Veel EM, Otto SA, Richter C, Soetekouw R, Prins JM, Brinkman K, Mulder JW, Kroon F, Middel A, Symons J, Wensing AM, Nijhuis M, Borghans JA, Tesselaar K, Hoepelman AI; MIRS study group. Maraviroc Intensification of cART in Patients with Suboptimal Immunological Recovery: A 48-Week, Placebo-Controlled Randomized Trial. PLoS One. 2015 Jul 24;10(7):e0132430. doi: 10.1371/journal.pone.0132430. eCollection 2015.
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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.
Andy IM Hoepelman, MD, PhD principal investigator
UMC Utrecht
10 sites 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 HIV Infections, run by S.F.L. van Lelyveld at 10 sites 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 10 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: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30% increase in CD4+ cell count after 48 weeks (time frame: 48 weeks). 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 NCT00875368, 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 10 Sep 2013.