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

Primary Purpose

HIV-1 Infection, HIV Infections

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK0518 (Raltegravir)

famotidine

omeprazole

About this trial

This is an interventional treatment trial for HIV-1 Infection focused on measuring Treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Period 1

Period 2

Period 3

Arm Description

MK0518

famotidine + MK0518

omeprazole + MK0518

Outcomes

Primary Outcome Measures

Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir

Area Under the Plasma Concentration-Time Curve and peak concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT01000818

First Posted

October 22, 2009

Last Updated

February 14, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01000818

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1 Infection, HIV Infections

Keywords

Treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Period 1

Arm Type

Experimental

Arm Description

MK0518

Arm Title

Period 2

Arm Type

Experimental

Arm Description

famotidine + MK0518

Arm Title

Period 3

Arm Type

Experimental

Arm Description

omeprazole + MK0518

Intervention Type

Drug

Intervention Name(s)

MK0518 (Raltegravir)

Other Intervention Name(s)

Raltegravir

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

famotidine

Intervention Description

Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518

Intervention Type

Drug

Intervention Name(s)

omeprazole

Intervention Description

20 mg oral tablet of omeprazole, once daily for 5 days

Primary Outcome Measure Information:

Title

Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir

Description

Area Under the Plasma Concentration-Time Curve and peak concentration

Time Frame

12 hours postdose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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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