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

Sponsor:	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, as a therapy for HIV-infected patients not previously treated.

Condition	Intervention	Phase
HIV Infections	Drug: Comparator: MK0518 Drug: Comparator: efavirenz Drug: Comparator: Truvada Drug: Comparator: Placebo to MK0518 Drug: Comparator: Placebo to efavirenz	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), 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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Raltegravir Truvada

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of patients who achieve HIV RNA <50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients who achieve HIV RNA <400 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Change from baseline in CD4 Cell Count at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
Evaluate the antiretroviral activity at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
Change from baseline in CD4 Cell Count at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
Number of patients with nervous system symptoms assessed by review of accumulated safety data up to Week 8 [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
Number of patients with clinical adverse experiences (CAEs) at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients with serious CAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients with drug-related CAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients with serious drug-related CAEs at 48 weeks [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
Number of patients that died by 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients that discontinued with CAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients that discontinued with drug-related CAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients that discontinued with serious CAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients that discontinued with serious drug-related CAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients with laboratory adverse experiences (LAEs) at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients with drug-related LAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients with serious LAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients discontinued with laboratory adverse experiences (LAEs) at 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
Number of patients discontinued with drug-related LAEs at 96 weeks [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	550
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental MK0518 + placebo to efavirenz + Truvada	Drug: Comparator: MK0518 400 mg MK0518 tablet taken PO b.i.d. for up to 48 weeks Drug: Comparator: Truvada one tablet Truvada q.d. for up to 48 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir) Drug: Comparator: Placebo to efavirenz placebo to efavirenz PO q.h.s., taken for up to 48 weeks
Group 2: Active Comparator efavirenz + placebo to MK0518 + Truvada	Drug: Comparator: efavirenz 600 mg efavirenz tablet taken PO q.h.s. for up to 48 weeks Drug: Comparator: Truvada one tablet Truvada q.d. for up to 48 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir) Drug: Comparator: Placebo to MK0518 placebo to MK0518 PO b.i.d., taken for up to 48 weeks

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 naïve 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 by Merck

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. Epub 2009 Aug 3.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_519, MK0518-021
Study First Received:	August 29, 2006
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00369941 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Efavirenz
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010