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)

This study is ongoing, but not recruiting participants.

First Received: August 29, 2006 Last Updated: June 20, 2007 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00369941

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: 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	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Efavirenz Tenofovir disoproxil Tenofovir Disoproxil Fumarate Raltegravir Truvada

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of patients achieving HIV RNA <50 copies/mL [ Time Frame: At week 48 ]

Secondary Outcome Measures:

HIV RNA <400 copies [ Time Frame: At week 48 ]
Safety and tolerability of MK0518

Estimated Enrollment:	550
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369941

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2006_519
Study First Received:	August 29, 2006
Last Updated:	June 20, 2007
ClinicalTrials.gov Identifier:	NCT00369941 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Infective Agents
Efavirenz
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors

Virus Diseases
Emtricitabine
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on August 12, 2009