TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients
This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
|Official Title:||A Study to Survey the Swallowability of Uncoated 200-mg Tablets of Etravirine in HIV-1 Infected Subjects|
- Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet [ Time Frame: Assessment visit (Day 1) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
etravirine One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
This trial is designed to elicit the swallowability of two formulations of 200 mg tablets of etravirine (ETR). The trial will allow the assessment of the swallowability of the 200 mg uncoated tablet, the 200 mg film-coated tablet and make comparisons between these tablets and with the current commercially available 100 mg (uncoated) tablets. The trial will be performed in HIV-1 infected patients who are currently taking etravirine (ETR) at a total daily dose of 400 mg (four 100 mg tablets, as whole tablets orally) as part of an antiretroviral regimen with virologic suppression (< 50 copies/mL for at least three months). The trial includes only patients who are already taking etravirine since these patients will have pill taking experience and will also have experience with the commercially available 100 mg tablet formulation. A minimum of 45 patients will be included in the trial to assure a sample representative of the HIV-1 infected population. Patients will be given a single dose of the etravirine (ETR) uncoated 200 mg tablet in the morning, and then complete a questionnaire related to that intake. Within 30 minutes, they will be administered the coated 200 mg formulation, followed by a questionnaire. Assessments of the 200 mg tablets will be made in a single-blinded fashion. As the patient will be administered two 200mg tablets in the morning, he/she does not need to take an evening dose on the day of these assessments. The questionnaire will be used to assess swallowability of the 200 mg formulations and of their current 100 mg tablets, and will also evaluate patient preferences. Patients will be followed up for safety and tolerability for one week due to the short duration the patient will be on study treatment; it will be difficult to distinguish between Adverse Events (AEs) resulting from their current etravirine (ETR) intake (four 100 mg tablets) versus the study intake (two 200 mg tablets). A single dose of an etravirine uncoated 200 mg tablet in the morning, followed by completion of a questionnaire related to that intake. Within 30 minutes, patients will be administered the coated 200 mg formulation, again followed by a questionnaire. Maximum 2 weeks screening, 1 day treatment, 1 week follow up. Total duration of participation is 2 weeks maximum.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090648
|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|