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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000818
• Other study ID #: 0518-054
• Secondary ID: MK0518-0542009_6
• Status: Completed
• Phase: Phase 1
• First received: October 22, 2009
• Last updated: May 13, 2015
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-1 Infection
• Infection

Intervention

Drug:
• MK0518 (Raltegravir)
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.
• famotidine
Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
• omeprazole
20 mg oral tablet of omeprazole, once daily for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir	Area Under the Plasma Concentration-Time Curve and peak concentration	12 hours postdose	No