The Maraviroc Central Nervous System (CNS) Study

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00982878
First received: September 22, 2009
Last updated: September 17, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Maraviroc
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state. [ Time Frame: duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy [ Time Frame: duration of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc Drug: Maraviroc
150mg twice daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982878

Locations
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Pfizer
  More Information

No publications provided

Responsible Party: Alan Winston, Imperial College London
ClinicalTrials.gov Identifier: NCT00982878     History of Changes
Other Study ID Numbers: 2008-008437-10
Study First Received: September 22, 2009
Last Updated: September 17, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 09, 2014