TMC 125 Blood Levels Study
Summary
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.
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.
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Conditions
HIV Infections
Intervention
TMC125 once daily, TMC125 twice daily
Location
St Stephens Centre, Chelsea & Westminster Hospital
London
United Kingdom
SW10 9th
Status
Completed
Source
St Stephens Aids Trust
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00531323
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Energy Intake
Total number of calories taken in daily whether ingested or by parenteral routes.
Monitoring, Ambulatory
The use of electronic equipment to observe or record physiologic processes while the patient undergoes normal daily activities.
Leisure Activities
Voluntary use of free time for activities outside the daily routine.
Activities Of Daily Living
The performance of the basic activities of self care, such as dressing, ambulation, or eating.
Visually Impaired Persons
Persons with loss of vision such that there is an impact on activities of daily living.
Clinical Trials
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This is a Phase II, open-label, roll-over trial to evaluate the long-term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy (ART),...
The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and w...
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 copi...
The purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase Inhib...
PubMed Articles
Etravirine for the treatment of HIV/AIDS.
Introduction: Etravirine (TMC125) is an orally administered second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) that is approved in treatment-experienced patients as addition to a...
Once- vs Twice-Daily Budesonide/Formoterol in 6- to 15-Year-Old Patients With Stable Asthma.
Objective: To assess efficacy/tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide pMDI (primary) and twice-daily budesonide/formoterol (secondary...
OBJECTIVE: Despite the lack of any scientific data, many ART programs split the daily gonadotropin dose during ovarian stimulation, while others give the entire dose during a sin...
We evaluated, by Monte Carlo simulation, 500-mg once-daily, 100-mg thrice-daily, 200-mg twice-daily, and 200-mg thrice-daily dose regimens of levofloxacin (LVFX), for the ratio of area under the conce...
Effect of daily chlorhexidine bathing on hospital-acquired infection.
Results of previous single-center, observational studies suggest that daily bathing of patients with chlorhexidine may prevent hospital-acquired bloodstream infections and the acquisition of multidrug...
