The Effect of Antacids and Multivitamins on Raltegravir


Helen Reynolds

Status and phase

Phase 1




Dietary Supplement: Multivitamins
Drug: Raltegravir 400 mg
Dietary Supplement: Sodium bicarbonate
Drug: Maalox Plus extra

Study type


Funder types




Details and patient eligibility


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.


15 patients




18 to 60 years old


Accepts Healthy Volunteers

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

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

15 participants in 3 patient groups

Maalox Plus extra
Active Comparator group
Subjects will receive doses of raltegravir 400 mg and maalox plus extra
Drug: Maalox Plus extra
Drug: Raltegravir 400 mg
Active Comparator group
Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet
Drug: Raltegravir 400 mg
Dietary Supplement: Multivitamins
Sodium bicarbonate
Active Comparator group
Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate
Dietary Supplement: Sodium bicarbonate
Drug: Raltegravir 400 mg

Trial contacts and locations



Data sourced from

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