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Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01074931
First received: February 22, 2010
Last updated: July 7, 2011
Last verified: July 2011
Results First Received: May 20, 2011  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV-1 Infections
Intervention: Drug: Lopinavir/ritonavir (Kaletra)

  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
No text entered.

Reporting Groups
  Description
Lopinavir/Ritonavir Group Adult participants with HIV-1 infection taking lopinavir/ritonavir

Participant Flow:   Overall Study
    Lopinavir/Ritonavir Group
STARTED   98 
COMPLETED   92 
NOT COMPLETED   6 
Economic reasons                1 
Death                5 



  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.
No text entered.

Reporting Groups
  Description
Lopinavir/Ritonavir Group Adult participants with HIV-1 infection taking lopinavir/ritonavir

Baseline Measures
   Lopinavir/Ritonavir Group 
Overall Participants Analyzed 
[Units: Participants]
 98 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.86  (10.41) 
Gender 
[Units: Participants]
 
Female   27 
Male   71 
Region of Enrollment 
[Units: Participants]
 
China   98 
Age at HIV-1 Diagnosis [1] 
[Units: Years]
Mean (Standard Deviation)
 36.35  (10.89) 
[1] The mean age at which participants were diagnosed with HIV-1, based on 97 participants.
Participant Classification [1] 
[Units: Participants]
 
Treatment-experienced   90 
Treatment-naive   8 
[1] Participants were classified as either treatment-naive or treatment experienced.
WHO Clinical Staging [1] 
[Units: Participants]
 
Stage 1 (asymptomatic)   8 
Stage 2 (mild symptoms)   22 
Stage 3 (advanced symptoms)   32 
Stage 4 (severe symptoms)   36 
[1] Participants were staged according to the World Health Organization (WHO) clinical classification of established HIV infection: Stage 1 (asymptomatic), Stage 2 (mild symptoms), Stage 3 (advanced symptoms), and Stage 4 (severe symptoms).
Body Weight [1] 
[Units: Kilograms]
Mean (Standard Deviation)
 56.91  (11.14) 
[1] Participant body weight at study entry.
Lipodystrophy [1] 
[Units: Participants]
 
Lipodystrophy not present   56 
Mild lipodystrophy present   30 
Moderate lipodystrophy present   11 
Severe lipodystrophy present   1 
[1] The presence and severity of lipodystrophy (abnormal body fat distribution) at study entry.
Antiretroviral Treatment within Previous 6 Months [1] 
[Units: Particpants]
 
Yes   89 
No   8 
Not reported   1 
[1] Whether or not the participant had antiretroviral treatment within 6 months prior to study entry.
Other Chronic Diseases Present [1] 
[Units: Participants]
 
No   67 
Yes   29 
Not reported   2 
[1] Whether or not the participant had a chronic disease that had developed previously or was identified at study entry.


  Outcome Measures
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1.  Primary:   Evolution of the HIV Viral Response   [ Time Frame: Month 3, 6, 12, 18 ]

Measure Type Primary
Measure Title Evolution of the HIV Viral Response
Measure Description The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18  
Safety Issue No  

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.
All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.

Reporting Groups
  Description
Lopinavir/Ritonavir: Treatment-naive The subgroup of participants who had not received prior antiretroviral drug therapy.
Lopinavir/Ritonavir: Treatment-experienced The subgroup of participants who had previously received antiretroviral drug therapy.

Measured Values
   Lopinavir/Ritonavir: Treatment-naive   Lopinavir/Ritonavir: Treatment-experienced 
Participants Analyzed 
[Units: Participants]
 1   66 
Evolution of the HIV Viral Response 
[Units: Participant]
   
Viral load detectable at Baseline   0   51 
Viral load detectable at Visit 1   0   3 
Viral load detectable at Visit 2   0   12 
Viral load detectable at Visit 3   0   5 
Viral load detectable at Visit 4   0   5 
Viral load undetectable at Baseline   1   15 
Viral load undetectable at Visit 1   0   22 
Viral load undetectable at Visit 2   0   39 
Viral load undetectable at Visit 3   1   47 
Viral load undetectable at Visit 4   0   25 

No statistical analysis provided for Evolution of the HIV Viral Response



2.  Primary:   Evolution of CD4 Count   [ Time Frame: Month 3, 6, 12, 18 ]

Measure Type Primary
Measure Title Evolution of CD4 Count
Measure Description The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18  
Safety Issue No  

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.
Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point.

Reporting Groups
  Description
Lopinavir/Ritonavir: Treatment-naive The subgroup of participants who had not received prior antiretroviral drug therapy.
Lopinavir/Ritonavir: Treatment-experienced The subgroup of participants who had previously received antiretroviral drug therapy.

Measured Values
   Lopinavir/Ritonavir: Treatment-naive   Lopinavir/Ritonavir: Treatment-experienced 
Participants Analyzed 
[Units: Participants]
 8   90 
Evolution of CD4 Count 
[Units: Cells per cmm]
Mean (Standard Deviation)
   
CD4+ count at Baseline   101.00  (107.94)   249.03  (196.40) 
CD4+ count at Visit 1   136.67  (85.20)   285.96  (164.05) 
CD4+ count at Visit 2   200.57  (123.25)   317.10  (180.26) 
CD4+ count at Visit 3   200.00  (112.56)   378.56  (198.35) 
CD4+ count at Visit 4   239.00  (124.40)   413.77  (209.96) 

No statistical analysis provided for Evolution of CD4 Count



3.  Primary:   Evolution of the Tolerance Issues   [ Time Frame: Month 3, 6, 12, 18 ]

Measure Type Primary
Measure Title Evolution of the Tolerance Issues
Measure Description At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18  
Safety Issue Yes  

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.
All participants taking at least one dose of lopinavir/ritonavir.

Reporting Groups
  Description
Lopinavir/Ritonavir Group Adult participants with HIV-1 infection taking lopinavir/ritonavir

Measured Values
   Lopinavir/Ritonavir Group 
Participants Analyzed 
[Units: Participants]
 98 
Evolution of the Tolerance Issues 
[Units: Participants]
 
Lopinavir/ritonavir not tolerated at Visit 1   2 
Lopinavir/ritonavir not tolerated at Visit 2   0 
Lopinavir/ritonavir not tolerated at Visit 3   0 
Lopinavir/ritonavir not tolerated at Visit 4   0 

No statistical analysis provided for Evolution of the Tolerance Issues



4.  Secondary:   Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen   [ Time Frame: Month 3, 6, 12, 18 ]

Measure Type Secondary
Measure Title Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
Measure Description Visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The frequency with which each participant forgot to take their medication since the last visit and discontinuations of treatment and the reasons were documented at each visit and are summarized. The number of participants changing from lopinavir/ritonavir soft gel capsule to tablet are also presented. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month. Note: participants may have had multiple missed doses or therapy changes.
Time Frame Month 3, 6, 12, 18  
Safety Issue Yes  

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.
All participants who took at least one dose of lopinavir/ritonavir.

Reporting Groups
  Description
Lopinavir/Ritonavir Group Adult participants with HIV-1 infection taking lopinavir/ritonavir

Measured Values
   Lopinavir/Ritonavir Group 
Participants Analyzed 
[Units: Participants]
 98 
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen 
[Units: Participants]
 
Total Missed Doses   49 
a) Missed doses reported at Visit 1   9 
b) Missed doses reported at Visit 2   13 
c) Missed doses reported at Visit 3   17 
d) Missed doses reported at Visit 4   10 
Discontinued lopinavir/ritonavir therapy   6 
a) Discontinued due to serious adverse event   5 
b) Discontinued due to economic reasons   1 
Interrupted lopinavir/ritonavir therapy   4 
a) Interrupted due to adverse event   2 
b) Required treatment with prohibited medication   1 
c) Away because of work   1 
Therapy change: Switch from capsule to tablet   51 
a) Switch from capsule to tablet at Visit 1   35 
b) Switch from capsule to tablet at Visit 2   12 
c) Switch from capsule to tablet at Visit 3   4 
d) Switch from capsule to tablet at Visit 4   0 

No statistical analysis provided for Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen



5.  Secondary:   Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations   [ Time Frame: Month 3, 6, 12, 18 ]

Measure Type Secondary
Measure Title Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Measure Description The types of adverse events reported are summarized. The presence of lipodystrophy (abnormal body fat distribution) and its location was to be recorded. However, due to an oversight, there was not a place to record the location of lipodystrophy on the case report form. Doctors used clinical judgment to rate lipodystrophy in treatment-experienced participants. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18  
Safety Issue Yes  

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.
The adverse event population includes all participants who took at least one dose of lopinavir/ritonavir (98). Lipodystrophy evaluations were performed in treatment-experienced participants (90), not treatment-naive participants (8).

Reporting Groups
  Description
Lopinavir/Ritonavir Group Adult participants with HIV-1 infection taking lopinavir/ritonavir

Measured Values
   Lopinavir/Ritonavir Group 
Participants Analyzed 
[Units: Participants]
 98 
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations 
[Units: Participants]
 
Non-serious adverse events   1 
Serious adverse events   8 
Lipodystrophy: Visit 1 evaluation   90 
a) Improved   24 
b) Unchanged   65 
c) Worsened   1 
Lipodystrophy: Visit 2 evaluation   88 
a) Improved   8 
b) Unchanged   78 
c) Worsened   2 
Lipodystrophy: Visit 3 evaluation   87 
a) Improved   8 
b) Unchanged   79 
c) Worsened   0 
Lipodystrophy: Visit 4 evaluation   84 
a) Improved   9 
b) Unchanged   75 
c) Worsened   0 

No statistical analysis provided for Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations



6.  Secondary:   The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment   [ Time Frame: Month 3, 6, 12, 18 ]

Measure Type Secondary
Measure Title The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment
Measure Description As so few participants withdrew from lopinavir/ritonavir treatment, durations of lopinavir/ritonavir therapy required for 25 percent, 50 percent and 75 percent of participants could not be established. The numbers of participants in each subgroup who discontinued from treatment due to an adverse event are presented.
Time Frame Month 3, 6, 12, 18  
Safety Issue Yes  

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.
All participants who took at least one dose of lopinavir/ritonavir.

Reporting Groups
  Description
Lopinavir/Ritonavir Group: Treatment-naive The subgroup of participants who had not received prior antiretroviral drug therapy.
Lopinavir/Ritonavir Group: Treatment-experienced The subgroup of participants who had previously received antiretroviral drug therapy.

Measured Values
   Lopinavir/Ritonavir Group: Treatment-naive   Lopinavir/Ritonavir Group: Treatment-experienced 
Participants Analyzed 
[Units: Participants]
 8   90 
The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment 
[Units: Participants]
 1   5 

No statistical analysis provided for The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment




  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
The location of lipodystrophy was not summarized as there was not a place to record the information on the case report form. Too few participants withdrew from treatment to conduct planned analyses of duration to adverse event(s)/discontinuation.


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