Clinical trial NCT01784302: The Effect of Antacids and Multivitamins on Raltegravir
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in raltegravir Area under the curve (AUC)0-12h
timeFrame: Day 1, 6, 11, 16 and 21
Secondary outcomes:
measure: Measurement of gastrointestinal pH
timeFrame: Day 1, 6, 11, 16 and 21
measure: Number of adverse events
timeFrame: Day 1 up to end of study Day 27
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
Study officials:
affiliation: University of Liverpool
name: Saye Khoo, Prof
role: PRINCIPAL_INVESTIGATOR
References: