Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT00369941
Start Date
August 1 2006
End Date
February 1 2012
Last Update
March 21 2017
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