Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

HIV-1 Infection

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT01000818

Start Date

June 1 2008

End Date

March 1 2009

Last Update

March 21 2017

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