Back to resultsMK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
Primary Purpose
HIV Infection
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0518 (raltegravir)
Comparator: KALETRA™ (lopinavir (+) ritonavir )
Comparator: placebo
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring treatment experienced
Eligibility Criteria
Inclusion Criteria:
- Patient is at least 18 years of age
- Patient is Human Immunodeficiency Virus (HIV) positive
- Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
- Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
- Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen
Exclusion Criteria:
- Patient is or plans to become pregnant, or nursing a child
- Patient plans to donate eggs or impregnate/donate sperm
- Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
- Patient is currently receiving a second protease inhibitor in addition to KALETRA
- Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
- Patient has used another experimental HIV-integrase inhibitor
- Patient has a current (active) diagnosis of acute hepatitis due to any cause
- Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )
Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)
Outcomes
Primary Outcome Measures
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Median Percent Change From Baseline in Serum Triglyceride at Week 12
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Secondary Outcome Measures
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Median Percent Change From Baseline in Serum Triglyceride at Week 24
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Full Information
NCT ID
NCT00443703
First Posted
March 2, 2007
Last Updated
February 14, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00443703
Brief Title
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
Official Title
A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
treatment experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)
Intervention Type
Drug
Intervention Name(s)
MK0518 (raltegravir)
Other Intervention Name(s)
MK0518, raltegravir
Intervention Description
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Comparator: KALETRA™ (lopinavir (+) ritonavir )
Other Intervention Name(s)
KALETRA
Intervention Description
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.
Primary Outcome Measure Information:
Title
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
Time Frame
Week 24
Title
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
Description
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product
Time Frame
24 Week last patient last visit
Title
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
Time Frame
Baseline and Week 12
Title
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time Frame
Baseline and Week 12
Title
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame
Baseline and Week 12
Title
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame
Baseline and Week 12
Title
Median Percent Change From Baseline in Serum Triglyceride at Week 12
Description
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
Time Frame
Baseline and Week 24
Title
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Time Frame
Baseline and Week 24
Title
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Time Frame
Baseline and Week 24
Title
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Time Frame
Baseline and Week 24
Title
Median Percent Change From Baseline in Serum Triglyceride at Week 24
Description
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time Frame
Baseline and Week 24
Other Pre-specified Outcome Measures:
Title
Number of Patients With Serious CAEs Through 24 Weeks
Description
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
Time Frame
24 Week last patient last visit
Title
Number of Patients With Drug-related CAEs Through 24 Weeks
Description
Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.
Time Frame
24 Week last patient last visit
Title
Number of Patients With Serious Drug-related CAEs Through 24 Weeks
Description
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. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement
Time Frame
24 Week last patient last visit
Title
Number of Patients That Died by 24 Week Last Patient Last Visit
Time Frame
24 Week last patient last visit
Title
Number of Patients That Discontinued Due to CAEs Through 24 Weeks
Time Frame
24 Week last patient last visit
Title
Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks
Time Frame
24 Week last patient last visit
Title
Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Description
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product
Time Frame
24 Week last patient last visit
Title
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Description
Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs
Time Frame
24 Week last patient last visit
Title
Number of Patients With Serious LAEs Through 24 Weeks
Description
Serious LAEs are any LAEs 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
Time Frame
24 Week last patient last visit
Title
Number of Patients That Discontinued Due to LAEs Through 24 Weeks
Time Frame
24 Week last patient last visit
Title
Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks
Description
Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.
Time Frame
24 Week last patient last visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is at least 18 years of age
Patient is Human Immunodeficiency Virus (HIV) positive
Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen
Exclusion Criteria:
Patient is or plans to become pregnant, or nursing a child
Patient plans to donate eggs or impregnate/donate sperm
Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
Patient is currently receiving a second protease inhibitor in addition to KALETRA
Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
Patient has used another experimental HIV-integrase inhibitor
Patient has a current (active) diagnosis of acute hepatitis due to any cause
Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
20074791
Citation
Eron JJ, Young B, Cooper DA, Youle M, Dejesus E, Andrade-Villanueva J, Workman C, Zajdenverg R, Fatkenheuer G, Berger DS, Kumar PN, Rodgers AJ, Shaughnessy MA, Walker ML, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Xu X, Sklar P; SWITCHMRK 1 and 2 investigators. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet. 2010 Jan 30;375(9712):396-407. doi: 10.1016/S0140-6736(09)62041-9. Epub 2010 Jan 12.
Results Reference
derived
Learn more about this trial
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
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