The Effect of Antacids and Multivitamins on Raltegravir

This study is not yet open for participant recruitment.
Verified October 2013 by University of Liverpool
Sponsor:
Information provided by (Responsible Party):
Helen Reynolds, University of Liverpool
ClinicalTrials.gov Identifier:
NCT01784302
First received: January 28, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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
HIV
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Correlation between gastric pH and raltegravir pharmacokinetics

  • Number of adverse events [ Time Frame: Day 1 up to end of study Day 27 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784302

Contacts
Contact: Helen Reynolds her@liv.ac.uk

Locations
United Kingdom
Royal Liverpool University Hospital Not yet recruiting
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Helen Reynolds
Investigators
Principal Investigator: Saye Khoo, Prof University of Liverpool
  More Information

No publications provided

Responsible Party: Helen Reynolds, Research nurse, University of Liverpool
ClinicalTrials.gov Identifier: NCT01784302     History of Changes
Other Study ID Numbers: 4347
Study First Received: January 28, 2013
Last Updated: October 25, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Antacids
Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
Aluminum hydroxide, magnesium hydroxide, drug combination
TEMPO
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014