A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium; Tenofovir

Criteria

Inclusion Criteria:

• Participant is a male or female at least 18 years of age

• Participant is HIV positive

• Participant is naïve to antiretroviral therapy (ART) and has not received any ART

Exclusion Criteria:

• Participant has received approved or experimental antiretroviral agents in the past

• Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)

• Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz

• Participant has used another experimental HIV-integrase inhibitor

• Participant has a current (active) diagnosis of acute hepatitis due to any cause

• Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests