The Rilpivirine Cerebrospinal-fluid (CSF) Study

This study has been completed.
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01562886
First received: March 22, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
HIV
Drug: Rilpivirine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • CSF:Plasma Ratio of Rilpivirine Levels [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure


Secondary Outcome Measures:
  • Number of Subjects With HIV Viral Load Above 50 Copies Per mL [ Time Frame: Day 3,14, 28, 60, 80-100 ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 14
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rilpivirine and Truvada
TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Drug: Rilpivirine
Rilpivirine 26mg
Other Name: Edurant

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562886

Locations
United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Janssen-Cilag Ltd.
Investigators
Principal Investigator: Alan Winston, MBChB MD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01562886     History of Changes
Other Study ID Numbers: 278_CSF, 2011-004026-98
Study First Received: March 22, 2012
Results First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Rilpivirine CSF pharmacokinetics

ClinicalTrials.gov processed this record on July 29, 2014