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The Maraviroc Central Nervous System (CNS) Study

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Maraviroc

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring treatment experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maraviroc

Arm Description

Outcomes

Primary Outcome Measures

CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS)

To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state. It were assessed by in vivo cerebral (1)H magnetic resonance spectroscopy ((1)H-MRS). Cerebral MRS imaging (T1- and T2-weighted images) was performed on a Phillips Achieva™ 1.5 Tesla magnetic resonance (MR) scanner (Phillips NV, Best, Netherlands) and studied by an experienced neuroradiologist

Secondary Outcome Measures

Number of Participants With Adverse Events

To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy

Full Information

NCT ID

NCT00982878

First Posted

September 22, 2009

Last Updated

October 15, 2019

Sponsor

Imperial College London

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00982878

Brief Title

The Maraviroc Central Nervous System (CNS) Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 2009 (Actual)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Imperial College London

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Maraviroc

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Maraviroc

Intervention Description

150mg twice daily

Primary Outcome Measure Information:

Title

CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS)

Description

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Winston

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Imperial College Healthcare NHS Trust

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21987241

Citation

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.

Results Reference

result

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The Maraviroc Central Nervous System (CNS) Study

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