the effect of antacids and multivitamins on raltegravir

Conditions: HIV

Summary: this study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. the aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.


Eligibility criteria:
inclusion criteria: * 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. * ≥ 18 years * male or female subjects * a female may be eligible to enter and participate in the study if she: * is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or * is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy * complete abstinence from intercourse from 2 weeks prior to administration of ip, throughout the study and for at least 4 weeks after discontinuation of all study medication * double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide) * any intrauterine device (iud) with published data showing that the expected failure rate is \< 1 % per year * any other method with published data showing that the expected failure rate is \< 1 % per year * hormonal contraception plus a barrier method. hormonal contraception alone will not be considered adequate for inclusion into or participation in this study * male subjects with a female partner of childbearing potential must agree to use effective contraception as above unless vasectomized * all subjects participating in the study will be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom) exclusion criteria: * any significant acute or chronic medical condition * pregnant or lactating women * women of childbearing age unless using non hormonal contraception * evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations * abnormal lfts (alt \> 2.5 x uln, bilirubin \> 1.5 x uln) * positive blood screen for hiv-1 and 2 antibodies * positive blood screen for hepatitis b or c antibodies * current or recent (within 3 months) gastrointestinal disease * clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects * use of proton pump inhibitors * exposure to any investigational drug or placebo within 4 weeks of first dose of study drug * consumption of grapefruit and oranges or products containing grapefruit or oranges within 1 week of first study drug and for the duration of the study * use of any other drugs including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug * previous allergy to any of the constituents of the pharmaceuticals in this trial