A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)

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ClinicalTrials.gov Identifier: NCT01000818

Recruitment Status : Completed

First Posted : October 23, 2009

Results First Posted : May 28, 2010

Last Update Posted : March 21, 2017

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.

Condition or disease	Intervention/treatment	Phase
HIV-1 Infection HIV Infections	Drug: MK0518 (Raltegravir) Drug: famotidine Drug: omeprazole	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen
Study Start Date :	June 2008
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Omeprazole Famotidine Omeprazole magnesium Famotidine hydrochloride Raltegravir Raltegravir potassium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Period 1 MK0518	Drug: MK0518 (Raltegravir) 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. Other Name: Raltegravir
Experimental: Period 2 famotidine + MK0518	Drug: MK0518 (Raltegravir) 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. Other Name: Raltegravir Drug: famotidine Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
Experimental: Period 3 omeprazole + MK0518	Drug: MK0518 (Raltegravir) 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. Other Name: Raltegravir Drug: omeprazole 20 mg oral tablet of omeprazole, once daily for 5 days

Outcome Measures

Primary Outcome Measures :

Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir [ Time Frame: 12 hours postdose ]
Area Under the Plasma Concentration-Time Curve and peak concentration

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is Human immunodeficiency virus (HIV) positive
Patient is taking an MK0518 (Raltegravir) containing regimen
Patient has not had any changes to his/her antiviral regimen in the last 2 weeks
Patient who is of reproductive potential agrees to use an acceptable method of birth control
Patients baseline health is stable

Exclusion Criteria:

Patient has a history of stroke or chronic seizures.
Patient has a history of gastric bypass surgery
Patient is pregnant of breastfeeding
Patient consumes excessive amounts of caffeinated beverages daily
Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000818

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

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Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01000818
Other Study ID Numbers:	0518-054 MK0518-054 2009_681
First Posted:	October 23, 2009 Key Record Dates
Results First Posted:	May 28, 2010
Last Update Posted:	March 21, 2017
Last Verified:	February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Keywords provided by Merck Sharp & Dohme Corp.:


Treatment experienced

Additional relevant MeSH terms:

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Infections Communicable Diseases Disease Attributes Pathologic Processes Raltegravir Potassium Omeprazole Famotidine Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action	Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Physiological Effects of Drugs

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