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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: HIV-1 Infection; HIV Infections

Treatments: Drug: omeprazole; Drug: MK0518 (Raltegravir); Drug: famotidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01000818

0518-054

MK0518-054

2009_681

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Period 1

Experimental group

Description:

MK0518

Treatment:

Drug: MK0518 (Raltegravir)

Period 2

Experimental group

Description:

famotidine + MK0518

Treatment:

Drug: MK0518 (Raltegravir)

Drug: famotidine

Period 3

Experimental group

Description:

omeprazole + MK0518

Treatment:

Drug: MK0518 (Raltegravir)

Drug: omeprazole