TMC125-TiDP2-C188: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Patients on Stable Buprenorphine/Naloxone Maintenance Therapy.

June 8, 2011 updated by: Tibotec Pharmaceuticals, Ireland

A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy.

TMC125 is from the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make more copies of itself. TMC125 is used in the treatment of adults with HIV-1 infection. The purpose of this trial is to see if there is any potential interaction (change in the effectiveness of the drug) when taking multiple-dose TMC125 and buprenorphine/naloxone together. The trial will also assess the short-term safety and tolerability (how well your body handles the drug) when TMC125 and buprenorphine/naloxone are taken together.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase I, open-label (patient and trial doctor know what medication you are taking at any point in time during the trial), add-on trial in patients who are on stable sublingual (placed in the mouth under the tongue until it disolves) buprenorphine/naloxone maintenance therapy, to investigate the potential pharmacokinetic effect of multiple-dose TMC125 on buprenorphine and norbuprenorphine administered as buprenorphine/naloxone. The study population will consist of 16 HIV-negative opioid-dependent patients on stable individualized sublingual buprenorphine/naloxone maintenance therapy. Patients will first participate in a 2 weeks run-in period with supervised buprenorphine/naloxone intake. Subsequently, patients will receive TMC125 200 mg orally twice daily for 14 days added to their buprenorphine/naloxone treatment. During the treatment period from Day 1 to Day 14, the individualized buprenorphine/naloxone treatment will be continued with co-administration of TMC125. Full pharmacokinetic profiles of buprenorphine and norbuprenorphine will be determined on Days -1 and 14 up to 24 hours postdose. Full pharmacokinetic profiles of TMC125 will be determined on Day 14 up to 12 hours postdose. Pharmacodynamic assessments of symptoms of opiate withdrawal and excess will be performed. The short-term safety and tolerability will be assessed throughout the trial. Patients will firstparticipate in a 2 weeks run-in period with supervised buprenorphine/naloxone intake. Subsequently, patients will receive 2 tablets of 100 mg TMC125 twice daily for 14 days added to their buprenorphine/naloxone treatment. During the treatment period from Day 1 to Day 14, the individualized buprenorphine/naloxone treatment will be continued with co-administration of TMC125.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included. BMI is calculated as the weight (in kg) divided by the square of height (in m)
  • Receiving once daily buprenorphine/naloxone maintenance therapy at a stable individualized dose formulated and administered as sublingual tablets with a maximum daily dose of 16/4 mg of buprenorphine/naloxone. Patients using buprenorphine only are also eligible if they switch to buprenorphine/naloxone minimally 2 weeks before randomization
  • The patient agrees not to change the current buprenorphine/naloxone therapy from Screening until Day 14 included (switching buprenorphine to buprenorphine/naloxone between Screening and Day -14 is allowed)and to have a daily observed and documented buprenorphine/naloxone intake from Day -14 until Day 15
  • General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.

Exclusion Criteria:

  • A positive HIV-1 or HIV-2 test at Screening
  • Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post-tubal ligation (without reversal operation)
  • Evidence of current use of barbiturate, amphetamine, recreational or narcotic drug use (cocaine, inhalants, stimulants), sedative hypnotics (benzodiazepines), excessive alcohol or opioids. The drug screening involves analysis for amphetamines, barbiturates, benzodiazepines, cocaine and opioids
  • Hepatitis A infection (confirmed by hepatitis A antibody IgM), or hepatitis B infection (confirmed by hepatitis B surface antigen) at study screening
  • Currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective is to determine the effect of multiple-dose TMC125 on the steady-state pharmacokinetics of buprenorphine and its metabolite norbuprenorphine in HIV-negative patients during 2 weeks.

Secondary Outcome Measures

Outcome Measure
To determine the pharmacokinetics of TMC125, the pharmacodynamic effects of opiate excess or withdrawal and short-term safety and tolerability of the co-administration of TMC125 and buprenorphine/naloxone during 2 weeks of coadministration with TMC125.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tibotec Pharmaceuticals, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (ESTIMATE)

January 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR015775

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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