The Effect of Antacids and Multivitamins on Raltegravir

NCT01784302 | Completed Phase 1 Results 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. Data collected at the following time points: pre dose, 1, 2, 3, 4, 6, 8 10 and 12 h post dose on Days 1, 6, 11, 16 and 21.

  Day 1, 6, 11, 16 and 21, over dosing period of 0-12 h

Secondary Outcomes (2)

• Measurement of Gastrointestinal pH

  Day 1, 6, 11, 16 and 21, four hours post dose

• Number of Adverse Events

  Day 1 up to end of study Day 27

Study Arms (3)

Raltegravir plus Maalox Plus

ACTIVE COMPARATOR

Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus multivitamin (1 tablet), raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose on five separate days.

Dietary Supplement: Multivitamins; Dietary Supplement: Sodium bicarbonate; Drug: Maalox Plus extra; Drug: Raltegravir 400 mg

Raltegravir plus Multivitamin

ACTIVE COMPARATOR

Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus multivitamin (1 tablet), raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir plus sodium bicarbonate 1 g on five separate days.

Dietary Supplement: Multivitamins; Dietary Supplement: Sodium bicarbonate; Drug: Maalox Plus extra; Drug: Raltegravir 400 mg

Raltegravir plus Sodium bicarbonate

ACTIVE COMPARATOR

Subjects will be dosed with raltegravir 400 mg followed by raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir 400 mg plus multivitamin (1 tablet), on five separate days.

Dietary Supplement: Multivitamins; Dietary Supplement: Sodium bicarbonate; Drug: Maalox Plus extra; Drug: Raltegravir 400 mg

Interventions

Multivitamins DIETARY_SUPPLEMENT

Raltegravir plus Maalox Plus; Raltegravir plus Multivitamin; Raltegravir plus Sodium bicarbonate

Sodium bicarbonate DIETARY_SUPPLEMENT

Raltegravir plus Maalox Plus; Raltegravir plus Multivitamin; Raltegravir plus Sodium bicarbonate

Maalox Plus extra DRUG

Raltegravir plus Maalox Plus; Raltegravir plus Multivitamin; Raltegravir plus Sodium bicarbonate

Raltegravir 400 mg DRUG

Raltegravir plus Maalox Plus; Raltegravir plus Multivitamin; Raltegravir plus 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

Results Point of Contact

• Title: Prof Saye Khoo
• Organization: University of Liverpool

TherEx-trials@liverpool.ac.uk

Study Officials

• Saye Khoo, Prof

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• 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: August 17, 2026
• Results First Posted: August 17, 2026

Record last verified: 2026-08

Locations

GB (1)