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

Study Overview
=================
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.

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

Conditions
-----------------
HIV-1 Infection, HIV Infections

Intervention / Treatment
-----------------
* Drug: MK0518 (Raltegravir)
* Drug: famotidine
* Drug: omeprazole


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1<br>MK0518 | Drug: MK0518 (Raltegravir)<br>* 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.<br>* Other names: Raltegravir;|
| Experimental: Period 2<br>famotidine + MK0518 | Drug: MK0518 (Raltegravir)<br>* 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.<br>* Other names: Raltegravir;Drug: famotidine<br>* Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518<br>|
| Experimental: Period 3<br>omeprazole + MK0518 | Drug: MK0518 (Raltegravir)<br>* 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.<br>* Other names: Raltegravir;Drug: omeprazole<br>* 20 mg oral tablet of omeprazole, once daily for 5 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir | Area Under the Plasma Concentration-Time Curve and peak concentration | 12 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment experienced