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The Effect of Antacids and Multivitamins on Raltegravir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784302
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 25, 2016
Information provided by (Responsible Party):
Helen Reynolds, University of Liverpool

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Dietary Supplement: Multivitamins Dietary Supplement: Sodium bicarbonate Drug: Maalox Plus extra Drug: Raltegravir 400 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784302

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

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Responsible Party: Helen Reynolds, Research nurse, University of Liverpool Identifier: NCT01784302     History of Changes
Other Study ID Numbers: 4347
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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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