TMC 125 Blood Levels Study
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.
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.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
TMC125 once daily, TMC125 twice daily
St Stephens Centre, Chelsea & Westminster Hospital
St Stephens Aids Trust
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00531323
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Total number of calories taken in daily whether ingested or by parenteral routes.
The use of electronic equipment to observe or record physiologic processes while the patient undergoes normal daily 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.
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