ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Honolulu, Hawaii
- Philadelphia, Pennsylvania
- New York, New York
- Amsterdam,
- Amsterdam,
- Amsterdam,
- Arnhem,
- Haarlem,
- Leiden,
- Rotterdam,
- Rotterdam,
- Tilburg,
- Utrecht,
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:
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 | 13 | ||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
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 |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Alan Winston, Imperial College London | ||||
Study Sponsor ICMJE | Imperial College London | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
| ||||
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 |