The Maraviroc Central Nervous System (CNS) Study
|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|
- 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 ]
- 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 ]
|Study Start Date:||September 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982878
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, W2 1NY|