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
No text entered.

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  
Number of Participants  
[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  
Participant Classification [2]
[units: Participants]
 
Treatment-experienced     90  
Treatment-naive     8  
WHO Clinical Staging [3]
[units: Participants]
 
Stage 1 (asymptomatic)     8  
Stage 2 (mild symptoms)     22  
Stage 3 (advanced symptoms)     32  
Stage 4 (severe symptoms)     36  
Body Weight [4]
[units: kilograms]
Mean ± Standard Deviation
  56.91  ± 11.14  
Lipodystrophy [5]
[units: Participants]
 
Lipodystrophy not present     56  
Mild lipodystrophy present     30  
Moderate lipodystrophy present     11  
Severe lipodystrophy present     1  
Antiretroviral Treatment within Previous 6 Months [6]
[units: Particpants]
 
Yes     89  
No     8  
Not reported     1  
Other Chronic Diseases Present [7]
[units: participants]
 
No     67  
Yes     29  
Not reported     2  
[1] The mean age at which participants were diagnosed with HIV-1, based on 97 participants.
[2] Participants were classified as either treatment-naive or treatment experienced.
[3] 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).
[4] Participant body weight at study entry.
[5] The presence and severity of lipodystrophy (abnormal body fat distribution) at study entry.
[6] Whether or not the participant had antiretroviral treatment within 6 months prior to study entry.
[7] 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 ]

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

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

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 ]
  Hide Outcome Measure 4

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  
Number of 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 ]

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 ]


  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.


  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: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Yue Kang, Abbott China
ClinicalTrials.gov Identifier: NCT01074931     History of Changes
Other Study ID Numbers: P10-398
Study First Received: February 22, 2010
Results First Received: May 20, 2011
Last Updated: July 7, 2011
Health Authority: China: Food and Drug Administration