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Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00358917
First received: July 28, 2006
Last updated: April 7, 2011
Last verified: April 2011
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus Infections
Intervention: Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LPV/r 800/200 mg QD Tablet lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet
LPV/r 400/100 mg BID Tablet lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet

Participant Flow:   Overall Study
    LPV/r 800/200 mg QD Tablet   LPV/r 400/100 mg BID Tablet
STARTED   300   299 
COMPLETED   234   230 
NOT COMPLETED   66   69 
Adverse Event                14                21 
Withdrawal by Subject                5                7 
Lost to Follow-up                20                17 
Noncompliance                12                11 
Death                2                3 
Virologic failure                11                8 
Unable to Continue Participation                2                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
LPV/r 800/200 mg QD Tablet lopinavir/ritonavir 800/200 mg once daily (QD) tablet
LPV/r 400/100 mg BID Tablet lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
Total Total of all reporting groups

Baseline Measures
   LPV/r 800/200 mg QD Tablet   LPV/r 400/100 mg BID Tablet   Total 
Overall Participants Analyzed 
[Units: Participants]
 300   299   599 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.4  (9.22)   40.8  (8.63)   40.6  (8.92) 
Gender 
[Units: Participants]
     
Female   103   103   206 
Male   197   196   393 
Received Prior Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) 
[Units: Participants]
     
Received Prior NNRTI   264   241   505 
Did Not Receive Prior NNRTI   36   58   94 
Received Prior Nucleoside/nucleotide Reverse Transcriptase Inhibitor (NRTI) 
[Units: Participants]
     
Received Prior NRTI   299   297   596 
Did Not Receive Prior NRTI   1   2   3 
Received Prior Protease Inhibitor (PI) 
[Units: Participants]
     
Received Prior PI   140   136   276 
Did Not Receive Prior PI   160   163   323 
Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Count 
[Units: Cells/microliter]
Mean (Standard Deviation)
 239.3  (158.39)   268.3  (183.55)   253.9  (171.98) 
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level 
[Units: Log10 copies/milliliter (mL)]
Mean (Standard Deviation)
 4.26  (0.826)   4.26  (0.809)   4.26  (0.817) 


  Outcome Measures
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1.  Primary:   Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Week 48 (End of Study) ]

2.  Secondary:   Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48   [ Time Frame: Week 48 (End of Study) ]

3.  Secondary:   Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts   [ Time Frame: Week 48 (End of Study) ]

4.  Secondary:   Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir   [ Time Frame: Week 48 (End of Study) ]

5.  Secondary:   Percentage of Participants With New Primary Protease Mutations at Week 48   [ Time Frame: Week 48 (End of Study) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Information Specialist
Organization: Abbott
phone: 800-633-9110



Responsible Party: Barry Bernstein, MD, Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00358917     History of Changes
Other Study ID Numbers: M06-802
Study First Received: July 28, 2006
Results First Received: November 12, 2009
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration