HIV InfectionsPhase 1NCT00982878
The Maraviroc Central Nervous System (CNS) Study
A Phase 1 study testing Maraviroc in people with HIV Infections, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Feb 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
- Have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection by a HCV antibody or HCV PCR.
- Have screening laboratory results (haematology, chemistry, and urinalysis) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official title: The Penetration of Maraviroc Into the Central Nervous System in HIV-1 Infected Subjects on Stable Antiretroviral Therapy; a Phase I Pharmacokinetic Study
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.
Read the detailed description
15 HIV-1 infected subjects currently receiving stable antiretroviral therapy will be recruited. At study entry, within 14 days of screening procedures, subjects will commence maraviroc dosed at 150 mg twice daily. For the rest of study period antiretroviral therapy will comprise:
- Truvada™ one tablet once daily at 0900
- Kaletra™ two tablets twice daily 0900 and 2100
- maraviroc 150 mg twice daily at 0900 and 2100
Subjects will attend for regular clinic visits during study treatment phase.
On day 15, subjects will attend the unit in the morning prior to usual dosing time. Blood with be drawn to assess plasma maraviroc concentration pre dose and pre lumbar puncture. A lumbar puncture will be performed under standard aseptic techniques to asses CSF maraviroc concentration and routine CSF parameters.
On completion of this study visit, subjects will cease maraviroc, continue on their usual antiretroviral regimen and attend for a follow up visit 10 days later.
- Conditions
- HIV Infections
- Being tested
- Maraviroc
- Keywords
- 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
150mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Experimental | Not described Receives: Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Secondary outcomes (1)
Number of Participants With Adverse Events
To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Alan Winston, Imperial College London
- Investigators
- Alan Winston, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982878
- Sponsor's protocol ID
- 2008-008437-10
- Other IDs
- 2008
- Status last verified
- Oct 2019
- First submitted
- 22 Sep 2009
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21987241
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Penetration of Maraviroc Into the Central Nervous System in HIV-1 Infected Subjects on Stable Antiretroviral Therapy; a Phase I Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT00982878
- Acronym / sponsor ID
- 2008-008437-10
- Conditions
- HIV Infections
- Keywords
- treatment experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2009 (actual)
- Primary completion
- Jul 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
15 HIV-1 infected subjects currently receiving stable antiretroviral therapy will be recruited. At study entry, within 14 days of screening procedures, subjects will commence maraviroc dosed at 150 mg twice daily. For the rest of study period antiretroviral therapy will comprise:
- Truvada™ one tablet once daily at 0900
- Kaletra™ two tablets twice daily 0900 and 2100
- maraviroc 150 mg twice daily at 0900 and 2100
Subjects will attend for regular clinic visits during study treatment phase.
On day 15, subjects will attend the unit in the morning prior to usual dosing time. Blood with be drawn to assess plasma maraviroc concentration pre dose and pre lumbar puncture. A lumbar puncture will be performed under standard aseptic techniques to asses CSF maraviroc concentration and routine CSF parameters.
On completion of this study visit, subjects will cease maraviroc, continue on their usual antiretroviral regimen and attend for a follow up visit 10 days later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | Experimental | Drug: Maraviroc |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing
Key exclusion criteria (7 listed)
- 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:
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 |
|---|---|---|
| Maraviroc150mg twice daily | Drug | Maraviroc |
Primary outcome
CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS)
Time frame: 15 days
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
1 secondary outcome
Number of Participants With Adverse Events
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21987241Garvey 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.
- Individual participant dataSharing planned: No
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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.
Alan Winston principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maraviroc in people with HIV Infections, run by Imperial College London at 1 site in United Kingdom.
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 17 inclusion and 7 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 4 Nov 2019. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS) (time frame: 15 days). 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 NCT00982878, 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 4 Nov 2019.