The Maraviroc Central Nervous System (CNS) Study
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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 |
- 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 ]
| 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 |
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 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 June 18, 2013