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.

NCT00828815 | Completed Phase 1

• 1 other identifier: CR015775
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV; Pharmacokinetics

Keywords

HIV-negative; buprenorphine/nalaxone; norbuprenorphine; opioid-dependent; TMC125-TiDP2-C188; TMC125-C188; TMC125; HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

TMC125 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Links

• A Phase I, open-label study to investigate the pharmacokinetic effects of multiple-dose etravirine onbuprenorphine and norbuprenorphine administered in HIV-negative subjects on stablebuprenorphine/naloxone maintenance therapy.

MeSH Terms

Conditions

HIV Infections

Interventions

etravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 9, 2011

Record last verified: 2010-10