The Maraviroc Central Nervous System (CNS) Study
The Penetration of Maraviroc Into the Central Nervous System in HIV-1 Infected Subjects on Stable Antiretroviral Therapy; a Phase I Pharmacokinetic Study
1 other identifier
interventional
13
1 country
1
Brief Summary
The purpose of this study is to describe the Central Nervous System exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
November 4, 2019
CompletedNovember 4, 2019
October 1, 2019
10 months
September 22, 2009
September 23, 2019
October 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS)
To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state. It were assessed by in vivo cerebral (1)H magnetic resonance spectroscopy ((1)H-MRS). Cerebral MRS imaging (T1- and T2-weighted images) was performed on a Phillips Achieva™ 1.5 Tesla magnetic resonance (MR) scanner (Phillips NV, Best, Netherlands) and studied by an experienced neuroradiologist
15 days
Secondary Outcomes (1)
Number of Participants With Adverse Events
15 days
Study Arms (1)
Maraviroc
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- HIV-1 infected males or females
- signed informed consent
- plasma HIV RNA \< 50 copies/mL at screening and on at least one other occasion over the last 3 months
- currently receiving a stable antiretroviral regimen comprising of:
- tenofovir 245 mg daily
- emtricitabine 200 mg daily
- a boosted protease inhibitor
- no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing
- Between 18 to 65 years of age, inclusive
- subjects in good health upon medical history, physical exam, and laboratory testing
- Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study including 30 days following last dose of study drug:
- barrier contraceptives (condom, diaphragm with spermicide)
- IUD PLUS a barrier contraceptive
- Female subjects of childbearing potential must have a negative pregnancy test.
- Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 30 days following last dose of study drug.
- +2 more criteria
You may not qualify if:
- current alcohol abuse or drug dependence
- active opportunistic infection or significant co-morbidities including dementia
- current prohibited concomitant medication (as listed in section 4.1.4)
- Have a body mass index (BMI) \> 32
- Contraindication to lumbar puncture examination. Such as:
- Existing neurological diseases
- Bleeding disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Pfizercollaborator
Study Sites (1)
Imperial College Healthcare NHS Trust
London, W2 1NY, United Kingdom
Related Publications (1)
Garvey L, Nelson M, Latch N, Erlwein OW, Allsop JM, Mitchell A, Kaye S, Watson V, Back D, Taylor-Robinson SD, Winston A. CNS effects of a CCR5 inhibitor in HIV-infected subjects: a pharmacokinetic and cerebral metabolite study. J Antimicrob Chemother. 2012 Jan;67(1):206-12. doi: 10.1093/jac/dkr427. Epub 2011 Oct 10.
PMID: 21987241RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Alan Winston
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Winston
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Reader and Honorary HIV consultant
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 23, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2010
Study Completion
February 1, 2011
Last Updated
November 4, 2019
Results First Posted
November 4, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share