A Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA(TM)

Condition(s) targeted: HIV Infections

Intervention: MK0518, /Duration of Treatment : 96 Weeks (Drug); Comparator : efavirenz /Duration of Treatment : 96 Weeks (Drug); Comparator : emtricitabine (+) tenofovir disoproxil fumarate /Duration of Treatment : 96 Weeks (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

This study will investigate the safety and efficacy of MK0518 versus efavirenz, in combination with TRUVADA(TM), as a therapy for HIV-infected patients not previously treated.

Official title: A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA(TM)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Proportion of patients achieving HIV RNA <50 copies/mL

Secondary outcome:

HIV RNA <400 copies

Safety and tolerability of MK0518

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is a male or female at least 18 years of age

- Patient is HIV positive

- Patient is naive to antiretroviral therapy (ART) and has not received any ART

Exclusion Criteria:

- Patient has received approved or experimental antiretroviral agents in the past

- Patient 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)

- Patient has documented resistance to tenofovir, emtricitabine, and/or efavirenz

- Patient has used another experimental HIV-integrase inhibitor

- Patient has a current (active) diagnosis of acute hepatitis due to any cause

- Patients with chronic hepatitis including chronic hepatitis B and/or C may enter the

study as long as they have stable liver function tests

Starting date: August 2006
Last updated: June 20, 2007