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The Effect of Antacids and Multivitamins on Raltegravir
The Effect of Antacids and Multivitamins on Raltegravir

NCT01784302

CompletedPhase 1

Sponsor: Helen Reynolds

Conditions: HIV

Interventions: Multivitamins, Sodium bicarbonate, Maalox Plus extra, Raltegravir 400 mg

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (1)
  • Liverpool, United Kingdom