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The Rilpivirine Cerebrospinal-fluid (CSF) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562886
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : June 19, 2014
Last Update Posted : June 19, 2014
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.

Condition or disease Intervention/treatment Phase
HIV Drug: Rilpivirine Phase 1

Detailed Description:

To investigate the following parameters in HIV-infected patients switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine for 60 days:

  • CSF exposure and CSF : plasma ratio of rilpivirine
  • Safety and tolerability of switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine
  • Changes in cerebral metabolites measured via 1-H MRS after switching antiretroviral therapy to TDF/FTC/rilpivirine
  • Seminal fluid exposure of rilpivirine

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic Study to Assess the Cerebrospinal-fluid (CSF) Exposure of Rilpivirine in HIV-infected Subjects Switching From TDF/FTC/Nevirapine to TDF/FTC/Rilpivirine
Study Start Date : March 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Rilpivirine

Arm Intervention/treatment
Experimental: Rilpivirine and Truvada
TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Drug: Rilpivirine
Rilpivirine 26mg
Other Name: Edurant

Primary Outcome Measures :
  1. CSF:Plasma Ratio of Rilpivirine Levels [ Time Frame: Day 60 ]
    The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure

Secondary Outcome Measures :
  1. Number of Subjects With HIV Viral Load Above 50 Copies Per mL [ Time Frame: Day 3,14, 28, 60, 80-100 ]
    Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV-1 infected males subjects
  • signed informed consent
  • willing to switch therapy as per study protocol
  • no previous exposure to rilpivirine
  • 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 TDF/FTC with nevirapine with nevirapine dosed either 200 mg twice daily or 400 mg once daily with no antiretroviral drug switches for at least 3 months
  • no clinically-significant resistance documented on any prior HIV-1 genotypic resistance testing
  • subjects in good health upon medical history, physical exam, and laboratory testing
  • BMI above or equal to 18 and below 32
  • Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom and diaphragm) during heterosexual intercourse, from screening through completion of the study.
  • Have local screening laboratory results (haematology and chemistry 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
  • No contraindications to having a lumbar puncture examination found on MRI of the brain

Exclusion Criteria:

  • current alcohol abuse or drug dependence
  • positive urine drug of abuse screening
  • active opportunistic infection or significant co-morbidities
  • current disallowed concomitant medication (as listed in section 4.1.3)
  • contraindication to MR examination or lumbar puncture examination
  • recent head injury (in last 30 days) or chronic ongoing neurological diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01562886

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United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Janssen-Cilag Ltd.
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Principal Investigator: Alan Winston, MBChB MD Imperial College London
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Responsible Party: Imperial College London Identifier: NCT01562886    
Other Study ID Numbers: 278_CSF
2011-004026-98 ( EudraCT Number )
First Posted: March 26, 2012    Key Record Dates
Results First Posted: June 19, 2014
Last Update Posted: June 19, 2014
Last Verified: May 2014
Keywords provided by Imperial College London:
Rilpivirine CSF pharmacokinetics
Additional relevant MeSH terms:
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Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents