HIVPhase 1NCT01562886
The Rilpivirine Cerebrospinal-fluid (CSF) Study
A Phase 1 study testing Rilpivirine in people with HIV, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Rilpivirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Feb 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this 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
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.
Read the 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
- Conditions
- HIV
- Being tested
- Rilpivirine
- Keywords
- Rilpivirine CSF pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilpivirineDrug
Also called Edurant
Rilpivirine 26mg
| Study group | Role | What they receive |
|---|---|---|
| Rilpivirine and Truvada | Experimental | TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Receives: Drug: Rilpivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF:Plasma Ratio of Rilpivirine Levels
The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure
Measured: Day 60
Secondary outcomes (1)
Number of Subjects With HIV Viral Load Above 50 Copies Per mL
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)
Measured: Day 3,14, 28, 60, 80-100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
- Investigators
- Alan Winston, MBChB MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562886
- Sponsor's protocol ID
- 278_CSF
- Other IDs
- 2011-004026-98
- Status last verified
- May 2014
- First submitted
- 22 Mar 2012
- Last updated
- 19 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01562886
- Acronym / sponsor ID
- 278_CSF
- Conditions
- HIV
- Keywords
- Rilpivirine CSF pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Posted 19 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rilpivirine and Truvada | Experimental | Drug: RilpivirineTDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RilpivirineAlso: EdurantRilpivirine 26mg | Drug | Rilpivirine and Truvada |
Primary outcome
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
1 secondary outcome
Number of Subjects With HIV Viral Load Above 50 Copies Per mL
Time frame: Day 3,14, 28, 60, 80-100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Winston, MBChB MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rilpivirine in people with HIV, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF:Plasma Ratio of Rilpivirine Levels (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.