A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™
Sponsor study identifier
Secondary identifiers
OTHER · Merck
OTHER · Merck Registration ID
interventional
566
0 countries
N/A
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
February 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
August 29, 2006
Actual (reported)August 30, 2006
Actual (reported)May 2009
Actual (reported)May 11, 2010
Actual (reported)February 2012
Actual (reported)Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 48.
48 Weeks
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
48 Weeks
Number of Participants With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
48 Weeks
Number of Participants With Drug-related CAEs at Week 48
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
48 Weeks
Number of Participants With Serious Drug-related CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
48 Weeks
Number of Participants That Died by Week 48
All participant deaths in the span of 48 weeks on study were recorded.
48 Weeks
Number of Participants That Discontinued With CAEs at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
48 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
48 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 48
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
48 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
48 Weeks
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
48 Weeks
Number of Participants With Serious LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
48 Weeks
Number of Participants With Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
48 Weeks
Number of Participants With Serious Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
48 Weeks
Number of Participants Discontinued With LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
48 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse events (AEs) in this study were defined as "drug-related" if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone.
48 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
48 Weeks
Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
Baseline and Week 48
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
96 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
96 Weeks
Change From Baseline in CD4 Cell Count at Week 96
Baseline and Week 96
MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks
600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Comparator: Placebo to MK-0518
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordControl intervention
Comparator: Placebo to efavirenz
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordLennox 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. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3.
DeJesus E, Rockstroh JK, Lennox JL, Saag MS, Lazzarin A, Zhao J, Wan H, Rodgers AJ, Walker ML, Miller M, DiNubile MJ, Nguyen BY, Teppler H, Leavitt R, Sklar P; STARTMRK Investigators. Efficacy of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: week-192 overall and subgroup analyses from STARTMRK. HIV Clin Trials. 2012 Jul-Aug;13(4):228-32. doi: 10.1310/hct1304-228.
Medical Monitor
Merck Sharp & Dohme LLC
566 participants (actual enrollment reported by the registry).
First Submitted
August 29, 2006
First Posted
August 30, 2006
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks
Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rockstroh JK, Lennox JL, Dejesus E, Saag MS, Lazzarin A, Wan H, Walker ML, Xu X, Zhao J, Teppler H, Dinubile MJ, Rodgers AJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK. Clin Infect Dis. 2011 Oct;53(8):807-16. doi: 10.1093/cid/cir510.
Rockstroh J, Teppler H, Zhao J, Sklar P, Harvey C, Strohmaier K, Leavitt R, Nguyen BY. Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection. HIV Med. 2012 Feb;13(2):127-31. doi: 10.1111/j.1468-1293.2011.00933.x. Epub 2011 May 22.
Rockstroh JK, Teppler H, Zhao J, Sklar P, Miller MD, Harvey CM, Strohmaier KM, Leavitt RY, Nguyen BY. Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies. AIDS. 2011 Jul 17;25(11):1365-9. doi: 10.1097/QAD.0b013e328348065a.
Nguyen BY, Isaacs RD, Teppler H, Leavitt RY, Sklar P, Iwamoto M, Wenning LA, Miller MD, Chen J, Kemp R, Xu W, Fromtling RA, Vacca JP, Young SD, Rowley M, Lower MW, Gottesdiener KM, Hazuda DJ. Raltegravir: the first HIV-1 integrase strand transfer inhibitor in the HIV armamentarium. Ann N Y Acad Sci. 2011 Mar;1222:83-9. doi: 10.1111/j.1749-6632.2011.05972.x.
Teppler H, Brown DD, Leavitt RY, Sklar P, Wan H, Xu X, Lievano F, Lehman HP, Mast TC, Nguyen BY. Long-term safety from the raltegravir clinical development program. Curr HIV Res. 2011 Jan;9(1):40-53. doi: 10.2174/157016211794582650.
Lennox JL, Dejesus E, Berger DS, Lazzarin A, Pollard RB, Ramalho Madruga JV, Zhao J, Wan H, Gilbert CL, Teppler H, Rodgers AJ, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses. J Acquir Immune Defic Syndr. 2010 Sep;55(1):39-48. doi: 10.1097/QAI.0b013e3181da1287.
Primary Completion
May 2009
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
March 21, 2017
Results First Posted
May 11, 2010
Record last verified: 2017-02
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
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Source: ClinicalTrials.gov.
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