The Maraviroc Central Nervous System (CNS) Study

NCT00982878

Last updated date
Study Location
Imperial College Healthcare NHS Trust
London, , W2 1NY, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE The Maraviroc Central Nervous System (CNS) Study
Official Title  ICMJE The Penetration of Maraviroc Into the Central Nervous System in HIV-1 Infected Subjects on Stable Antiretroviral Therapy; a Phase I Pharmacokinetic Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: Maraviroc
150mg twice daily
Study Arms  ICMJE Experimental: Maraviroc
Intervention: Drug: Maraviroc
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2019)
13
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)
15
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00982878
Other Study ID Numbers  ICMJE 2008-008437-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Alan Winston, Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Alan WinstonImperial College London
PRS Account Imperial College London
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP