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

January 28, 2013
October 25, 2013
December 2013
May 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01784302 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Antacids and Multivitamins on Raltegravir
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Dietary Supplement: Multivitamins
  • Dietary Supplement: Sodium bicarbonate
  • Drug: Maalox Plus extra
  • Drug: Raltegravir 400 mg
  • Active Comparator: Maalox Plus extra
    Subjects will receive doses of raltegravir 400 mg and maalox plus extra
    Interventions:
    • Drug: Maalox Plus extra
    • Drug: Raltegravir 400 mg
  • Active Comparator: Multivitamin
    Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet
    Interventions:
    • Dietary Supplement: Multivitamins
    • Drug: Raltegravir 400 mg
  • Active Comparator: Sodium bicarbonate
    Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate
    Interventions:
    • Dietary Supplement: Sodium bicarbonate
    • Drug: Raltegravir 400 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
December 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Helen Reynolds her@liv.ac.uk
United Kingdom
 
NCT01784302
4347
Yes
Helen Reynolds, University of Liverpool
Helen Reynolds
Not Provided
Principal Investigator: Saye Khoo, Prof University of Liverpool
University of Liverpool
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP