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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
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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


  Outcome Measures
  Show All Outcome Measures

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.


  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