The Effect of Antacids and Multivitamins on Raltegravir

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784302
• Other study ID #: 4347
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2013
• Last updated: February 24, 2016
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Dietary Supplement:
• Multivitamins

• Sodium bicarbonate

Drug:
• Maalox Plus extra

• Raltegravir 400 mg

Locations

Country	Name	City	State
United Kingdom	Royal Liverpool University Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Helen Reynolds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measurement of gastrointestinal pH	Correlation between gastric pH and raltegravir pharmacokinetics	Day 1, 6, 11, 16 and 21	No
Secondary	Number of adverse events		Day 1 up to end of study Day 27	Yes