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The Rilpivirine Cerebrospinal-fluid (CSF) Study

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ClinicalTrials.gov Identifier: NCT01562886
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : June 19, 2014
Last Update Posted : June 19, 2014
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 26, 2012
Results First Submitted Date  ICMJE May 19, 2014
Results First Posted Date  ICMJE June 19, 2014
Last Update Posted Date June 19, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
Number of Subjects With HIV Viral Load Above 50 Copies Per mL [ Time Frame: Day 3, 7, 14, 28, 42, 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Rilpivirine Cerebrospinal-fluid (CSF) Study
Official Title  ICMJE 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
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.
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
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
Intervention  ICMJE Drug: Rilpivirine
Rilpivirine 26mg
Other Name: Edurant
Study Arms  ICMJE Experimental: Rilpivirine and Truvada
TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Intervention: Drug: Rilpivirine
Publications * Not Provided

*   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
 (submitted: May 2, 2014)
14
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2012)
15
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (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 NCT01562886
Other Study ID Numbers  ICMJE 278_CSF
2011-004026-98 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Janssen-Cilag Ltd.
Investigators  ICMJE
Principal Investigator: Alan Winston, MBChB MD Imperial College London
PRS Account Imperial College London
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP