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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.
Information provided by:
Abbott Identifier:
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
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Reporting Groups
Lopinavir/Ritonavir Group Adult participants with HIV-1 infection taking lopinavir/ritonavir

Participant Flow:   Overall Study
    Lopinavir/Ritonavir Group  
STARTED     98  
COMPLETED     92  
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.
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Reporting Groups
Lopinavir/Ritonavir Group Adult participants with HIV-1 infection taking lopinavir/ritonavir

Baseline Measures
    Lopinavir/Ritonavir Group  
Number of Participants  
[units: participants]
[units: years]
Mean (Standard Deviation)
  39.86  (10.41)  
[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 ]

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.

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