An open-label, two-period, crossover, pharmacokinetic study of abacavir and its intracellular anabolite carbovir triphosphate following once-daily and twice-daily administration of abacavir in HIV-infected subjects. - CAL102120

GlaxoSmithKline R&D UK Ltd0 sites30 target enrollmentJune 22, 2005

Overview

No summary available.

Registry

who.int

Start Date

June 22, 2005

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GlaxoSmithKline R&D UK Ltd

•Healthy adult male or female aged 18\-65 years. Females should be of non\-childbearing potential or with a negative pregnancy test at screening and agrees to use a form of contraception as detailed in the protocol.
•Able and willing to give written informed consent to participate in the study.
•Documented HIV\-1 infection (documented by historical data or current validated assay).
•Undetectable viral load, as determined by an ultra\-sensitive assay (\<400 copies/mL) at screening.
•Currently on an ABC\-containing regimen for at least 8 weeks. A stable regimen of other approved antiretroviral agents (except for tenofovir) is permitted. However, other than switching from ABC BID to QD or vice versa, as per this protocol, there should be no plans to change any component of the antiretroviral regimen until study completion.
•CD4\+ cell count \> or \=250 cells/mm3 at screening.
•Willingness to temporarily switch ABC schedule from BID to QD, or vice versa, for 11 days.
•Weigh between 40\-100kg, inclusive and have a Body Mass Index within 19 to 29kg/m2 inclusive.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the subject unsuitable for the study.
•Subjects who have been on an ABC\-containing regimen for less than 8 weeks.
•Subjects that have missed any scheduled doses of ABC during the 3 days prior to the start of the study (Day –3 to –1 inclusive).
•Subjects who are receiving tenofovir.
•Previous study participation in other experimental drug trial(s) within 30 days before the screening phase of the study.
•Subjects who currently regularly take drugs\-of\-abuse, with the exception of cannabinoids.
•Subjects who cannot refrain from taking herbal remedies during the course of the study (from screening until discharge on Day 12\).
•Subjects who regularly consume more than an average of 4 units of alcohol per day (1 unit is defined as 83mL of a 12% strength beverage).
•Subjects with any condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug including, but not limited to, diabetes mellitus, hepatic impairment, renal impairment, hyperthyroidism, malabsorption syndrome.
•Poor general health preventing fasting or blood sampling, or any acute illness within seven days prior to dosing that would, in the judgement of the investigator, interfere with participation in the study;