Overview

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

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Famotidine
Omeprazole
Raltegravir Potassium
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