The Rilpivirine Cerebrospinal-fluid (CSF) Study

NCT01562886 | Completed Phase 1 Results

• 2 other identifiers: 278_CSF2011-004026-98
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Rilpivirine CSF pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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

  Day 60

Secondary Outcomes (1)

• Number of Subjects With HIV Viral Load Above 50 Copies Per mL

  Day 3,14, 28, 60, 80-100

Study Arms (1)

Rilpivirine and Truvada

EXPERIMENTAL

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

Drug: Rilpivirine

Interventions

Rilpivirine DRUG

Rilpivirine 26mg

Also known as: Edurant

Rilpivirine and Truvada

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Interventions

Rilpivirine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Borja Mora Peris
• Organization: Imperial College London

b.mora-peris@imperial.ac.uk

020 3312 6789

Study Officials

• Alan Winston, MBChB MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 19, 2014
• Results First Posted: June 19, 2014

Record last verified: 2014-05

Locations

GB (1)