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TMC 125 Blood Levels Study

This study has been completed.
Sponsor:
Information provided by:
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT00531323
First received: September 17, 2007
Last updated: September 4, 2008
Last verified: September 2008
History of Changes
  Purpose

The purpose of the study is to look at whether changing directly from one medication for HIV (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in the blood, compared to when TMC125 is taken without efavirenz having been taken immediately beforehand.

The study aims to help the investigators understand whether it is safe to change directly from efavirenz to TMC125 (with no gap between the treatments) in patients who need these treatments.

The study will investigate the blood levels of TMC125 when it is taken both once and twice a day.


Condition Intervention Phase
HIV Infections
 Drug: TMC125 once daily
Drug: TMC125 twice daily
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of the Pharmacokinetics and Safety of TMC125 Administered Once and Twice-Daily and Following a 2-Week-Treatment Period With Efavirenz in Male and Female Healthy Volunteers.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • Steady state plasma concentrations of TMC125 administered once and twice-daily and following a 2-week-treatment period with efavirenz 600 mg once daily [ Time Frame: 56 days ]

Secondary Outcome Measures:
  • Efavirenz inducing effect on TMC125 metabolism after efavirenz intake cessation evaluation. Safety and tolerability of TMC125 administered once and twice-daily [ Time Frame: 56 days ]

Estimated Enrollment: 24
Study Start Date: September 2007
Study Completion Date: December 2007
Arms Assigned Interventions
1
Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily
 Drug: TMC125 once daily
Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily
2
Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily
 Drug: TMC125 twice daily
Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily

Detailed Description:

Pharmacokinetic parameters of TMC125 will be evaluated when TMC125 is given without and with a 14-day efavirenz intake preceding period in order to evaluate the risk of achieving sub therapeutic concentrations of TMC125 when switching straight from efavirenz containing regimens

Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
  2. Male or non-pregnant, non-lactating females
  3. Between 18 to 65 years, inclusive
  4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive
  5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study

Exclusion Criteria:

  1. Any significant acute or chronic medical illness
  2. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
  3. Positive blood screen for hepatitis B and/or C antibodies
  4. Positive blood screen for HIV-1 and 2 antibodies
  5. Current or recent (within 3 months) gastrointestinal disease
  6. Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
  7. Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
  8. Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within 1 week of first dose of study drug and for the duration of the study
  9. Use of any other drugs, including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
  10. Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
  11. Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531323

Locations
United Kingdom
St Stephens Centre, Chelsea & Westminster Hospital
London, United Kingdom, SW10 9th
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Marta Boffito Chelsea & Westminser Healthcare NHS Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00531323     History of Changes
Other Study ID Numbers: SSAT 024
Study First Received: September 17, 2007
Last Updated: September 4, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by St Stephens Aids Trust:
Pharmacokinetic
TMC125
Healthy volunteers
Efavarinz

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013