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MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)

This study has been terminated.
(Primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00443729
First received: March 2, 2007
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
Results First Received: October 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: Comparator: raltegravir
Drug: Comparator: placebo
Drug: Comparator: lopinavir (+) ritonavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III; First Patient In: 11-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 17-Oct- 2008 34 Sites (US, Peru, Brazil, Colombia, Mexico, South Africa, Thailand, India, and Australia).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HIV-seropositive patients who were ≥18 years old, had documented HIV RNA <50 copies/mL for at least 3 months, had been on a KALETRA™-based regimen for at least 3 months without a change in background antiretroviral therapy, and had no documentation of HIV RNA >50 copies/mL for at least 3 months.

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Participant Flow:   Overall Study
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
STARTED     176     179  
Treated     176     178  
COMPLETED     166     172  
NOT COMPLETED     10     7  
Never Treated                 0                 1  
Lack of Efficacy                 4                 2  
Lost to Follow-up                 0                 1  
Physician Decision                 2                 1  
Protocol Violation                 1                 1  
Withdrawal by Subject                 3                 1  



  Baseline Characteristics
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Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
Total Total of all reporting groups

Baseline Measures
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.     Total  
Number of Participants  
[units: participants]
 		  176     178     354  
Age  
[units: Years]
Mean ( Full Range ) 		  42.0  
  ( 21 to 71 )   		  41.9  
  ( 23 to 74 )   		  42.0  
  ( 21 to 74 )  
Gender  
[units: participants]
 		     
Female     39     40     79  
Male     137     138     275  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     68     73     141  
Not Hispanic or Latino     108     105     213  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     1     1  
Asian     26     28     54  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     33     25     58  
White     85     81     166  
More than one race     32     42     74  
Unknown or Not Reported     0     0     0  
Cluster of Differentiation 4 (CD4) Cell Count  
[units: cells/mm3]
Mean ( Full Range ) 		  470.8  
  ( 16 to 1916 )   		  482.4  
  ( 100 to 1744 )   		  476.6  
  ( 16 to 1916 )  
Fasting (non-random) serum High-Density Lipoprotein-Cholesterol (HDL-C)  
[units: mg/dL]
Mean ± Standard Deviation 		  46.5  ± 12.8     47.9  ± 12.7     47.2  ± 12.7  
Fasting (non-random) serum Low-Density Lipoprotein-Cholesterol (LDL-C)  
[units: mg/dL]
Mean ± Standard Deviation 		  103.5  ± 41.0     104.3  ± 30.6     103.9  ± 36.2  
Fasting (non-random) serum cholesterol  
[units: mg/dL]
Mean ± Standard Deviation 		  214.7  ± 69.7     210.8  ± 46.4     212.7  ± 59.2  
Fasting (non-random) serum triglyceride [1]
[units: mg/dL]
Mean ± Standard Deviation 		  204.5  ± 156.3     217.5  ± 156.3     212.5  ± 156.3  
Non-HDL-C  
[units: mg/dL]
Mean ± Standard Deviation 		  168.2  ± 71.8     163.4  ± 45.7     165.8  ± 60.3  
[1] Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.



  Outcome Measures
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1.  Primary:   Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 1

2.  Primary:   Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
  Show Outcome Measure 2

3.  Primary:   Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 3

4.  Primary:   Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 4

5.  Primary:   Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 5

6.  Primary:   Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 6

7.  Primary:   Median Percent Change From Baseline in Serum Triglyceride at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 7

8.  Secondary:   Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 8

9.  Secondary:   Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 9

10.  Secondary:   Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 10

11.  Secondary:   Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 11

12.  Secondary:   Median Percent Change From Baseline in Serum Triglyceride at Week 24   [ Time Frame: Baseline and Week 24 ]
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13.  Other Pre-specified:   Number of Patients With Serious CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
  Show Outcome Measure 13

14.  Other Pre-specified:   Number of Patients With Drug-related CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
  Show Outcome Measure 14

15.  Other Pre-specified:   Number of Patients With Serious Drug-related CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
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16.  Other Pre-specified:   Number of Patients That Died by 24 Week Last Patient Last Visit   [ Time Frame: 24 Week last patient last visit ]
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17.  Other Pre-specified:   Number of Patients That Discontinued Due to CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
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18.  Other Pre-specified:   Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
  Show Outcome Measure 18

19.  Other Pre-specified:   Number of Patients With Drug-related LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
  Show Outcome Measure 19

20.  Other Pre-specified:   Number of Patients With Serious LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
  Show Outcome Measure 20

21.  Other Pre-specified:   Number of Patients That Discontinued Due to LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]
  Show Outcome Measure 21


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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