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The Effect of Antacids and Multivitamins on Raltegravir

This study has been completed.
Information provided by (Responsible Party):
Helen Reynolds, University of Liverpool Identifier:
First received: January 28, 2013
Last updated: February 24, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Dietary Supplement: Multivitamins
Dietary Supplement: Sodium bicarbonate
Drug: Maalox Plus extra
Drug: Raltegravir 400 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by University of Liverpool:

Primary Outcome Measures:
  • Change in raltegravir Area under the curve (AUC)0-12h [ Time Frame: Day 1, 6, 11, 16 and 21 ]
    The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin

Secondary Outcome Measures:
  • Measurement of gastrointestinal pH [ Time Frame: Day 1, 6, 11, 16 and 21 ]
    Correlation between gastric pH and raltegravir pharmacokinetics

  • Number of adverse events [ Time Frame: Day 1 up to end of study Day 27 ]

Enrollment: 15
Study Start Date: April 2014
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Maalox Plus extra
Subjects will receive doses of raltegravir 400 mg and maalox plus extra
Drug: Maalox Plus extra Drug: Raltegravir 400 mg
Active Comparator: Multivitamin
Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet
Dietary Supplement: Multivitamins Drug: Raltegravir 400 mg
Active Comparator: Sodium bicarbonate
Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate
Dietary Supplement: Sodium bicarbonate Drug: Raltegravir 400 mg


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01784302

United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Helen Reynolds
Principal Investigator: Saye Khoo, Prof University of Liverpool
  More Information

Responsible Party: Helen Reynolds, Research nurse, University of Liverpool Identifier: NCT01784302     History of Changes
Other Study ID Numbers: 4347
Study First Received: January 28, 2013
Last Updated: February 24, 2016

Additional relevant MeSH terms:
Raltegravir Potassium
Aluminum hydroxide, magnesium hydroxide, drug combination
Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Protective Agents
Physiological Effects of Drugs processed this record on April 25, 2017