The Rilpivirine Cerebrospinal-fluid (CSF) Study

• 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: Imperial College London
• Collaborator: Janssen-Cilag Ltd.
• Information provided by (Responsible Party): Imperial College London

Tracking Information

• First Submitted Date: March 22, 2012
• First Posted Date: March 26, 2012
• Results First Submitted Date: May 19, 2014
• Results First Posted Date: June 19, 2014
• Last Update Posted Date: June 19, 2014
• Study Start Date: March 2012
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: The Rilpivirine Cerebrospinal-fluid (CSF) Study
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV

Intervention

Drug: Rilpivirine

Rilpivirine 26mg

Other Name: Edurant

Study Arms

Experimental: Rilpivirine and Truvada

TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily

Intervention: Drug: Rilpivirine

• Publications *: Not Provided

Recruitment Information

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

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01562886
• Other Study ID Numbers: 278_CSF; 2011-004026-98 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Imperial College London
• Study Sponsor: Imperial College London
• Collaborators: Janssen-Cilag Ltd.

Investigators

• Principal Investigator: Alan Winston, MBChB MD; Imperial College London

• PRS Account: Imperial College London
• Verification Date: May 2014