Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00262522
First received: December 5, 2005
Last updated: February 3, 2012
Last verified: February 2012
Results First Received: July 9, 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 or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

  Participant Flow


  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 800/200 mg QD SGC (Through Week 8) lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
LPV/r 400/100 mg BID Tablet lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
LPV/r 400/100 mg BID SGC (Through Week 8) lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
Total Total of all reporting groups

Baseline Measures
    LPV/r 800/200 mg QD Tablet     LPV/r 800/200 mg QD SGC (Through Week 8)     LPV/r 400/100 mg BID Tablet     LPV/r 400/100 mg BID SGC (Through Week 8)     Total  
Number of Participants  
[units: participants]
  167     166     166     165     664  
Age  
[units: years]
Mean ± Standard Deviation
  38.7  ± 9.80     38.2  ± 9.63     38.3  ± 9.69     39.5  ± 10.31     38.7  ± 9.85  
Gender  
[units: participants]
         
Female     36     31     39     38     144  
Male     131     135     127     127     520  
CD4+ T Cell Count [1]
[units: cells/mm3]
Mean ± Standard Deviation
  209.9  ± 125.10     222.6  ± 127.37     226.4  ± 136.64     202.9  ± 139.57     215.5  ± 132.34  
Plasma HIV-1 RNA Level  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  4.92  ± 0.64     4.94  ± 0.67     5.04  ± 0.68     5.06  ± 0.64     4.99  ± 0.66  
[1] For once daily (QD) soft gel capsule (SGC), N=165.



  Outcome Measures
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1.  Primary:   Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks   [ Time Frame: Week 8 ]

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

3.  Secondary:   Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96   [ Time Frame: Week 96 (End of Study) ]

4.  Secondary:   Mean Change From Baseline to Week 96 in CD4+ T Cell Counts   [ Time Frame: Week 96 (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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