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