The Effect of Antacids and Multivitamins on Raltegravir

NCT01784302 | Completed Phase 1 DMC

• 1 other identifier: 4347
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Change in raltegravir Area under the curve (AUC)0-12h

  The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin

  Day 1, 6, 11, 16 and 21

Secondary Outcomes (2)

• Measurement of gastrointestinal pH

  Day 1, 6, 11, 16 and 21

• Number of adverse events

  Day 1 up to end of study Day 27

Study Arms (3)

Maalox Plus extra

ACTIVE COMPARATOR

Subjects will receive doses of raltegravir 400 mg and maalox plus extra

Drug: Maalox Plus extra; Drug: Raltegravir 400 mg

Multivitamin

ACTIVE COMPARATOR

Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet

Dietary Supplement: Multivitamins; Drug: Raltegravir 400 mg

Sodium bicarbonate

ACTIVE COMPARATOR

Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate

Dietary Supplement: Sodium bicarbonate; Drug: Raltegravir 400 mg

Interventions

Multivitamins DIETARY_SUPPLEMENT

Multivitamin

Sodium bicarbonate DIETARY_SUPPLEMENT

Sodium bicarbonate

Maalox Plus extra DRUG

Maalox Plus extra

Raltegravir 400 mg DRUG

Maalox Plus extra; Multivitamin; Sodium bicarbonate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helen Reynolds: lead

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Interventions

Geritol; Sodium Bicarbonate; aluminum hydroxide, magnesium hydroxide, drug combination; Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Saye Khoo, Prof

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research nurse

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: February 5, 2013
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

GB (1)