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Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01153269
First received: February 26, 2010
Last updated: November 16, 2011
Last verified: November 2011
Results First Received: November 16, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus-Infection
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
HIV-infected Participants With Hepatitis Co-infection HIV-infected participants with co-infections of hepatitis B or hepatitis C.

Participant Flow:   Overall Study
    HIV-infected Participants With Hepatitis Co-infection  
STARTED     33  
Participants Analyzed     33  
COMPLETED     31  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Antiretroviral therapy break                 1  



  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
HIV-infected Participants With Hepatitis Co-infection HIV-infected participants with co-infections of hepatitis B or hepatitis C.

Baseline Measures
    HIV-infected Participants With Hepatitis Co-infection  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Mean ± Standard Deviation
  42.4  ± 7.1  
Gender  
[units: participants]
 
Female     8  
Male     25  
Region of Enrollment  
[units: participants]
 
Germany     33  
Hepatitis Co-infection [1]
[units: participants]
 
Chronic hepatitis B     9  
Chronic hepatitis C     24  
Duration of HIV infection [2]
[units: years]
Mean ± Standard Deviation
  9.7  ± 7.4  
[1] The number of participants with hepatitis B or hepatitis C co-infection.
[2] How long participants had been diagnosed with HIV infection at Baseline. Based on 32 participants.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Baseline ]

2.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 4 ]

3.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 12 ]

4.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 24 ]

5.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 36 ]

6.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 48 ]

7.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 60 ]

8.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 72 ]

9.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 84 ]

10.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 96 ]

11.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 108 ]

12.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 120 ]

13.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 132 ]

14.  Primary:   Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters   [ Time Frame: Week 144 ]

15.  Primary:   Viral Load   [ Time Frame: Baseline ]

16.  Primary:   Viral Load   [ Time Frame: Week 4 ]

17.  Primary:   Viral Load   [ Time Frame: Week 12 ]

18.  Primary:   Viral Load   [ Time Frame: Week 24 ]

19.  Primary:   Viral Load   [ Time Frame: Week 36 ]

20.  Primary:   Viral Load   [ Time Frame: Week 48 ]

21.  Primary:   Viral Load   [ Time Frame: Week 60 ]

22.  Primary:   Viral Load   [ Time Frame: Week 72 ]

23.  Primary:   Viral Load   [ Time Frame: Week 84 ]

24.  Primary:   Viral Load   [ Time Frame: Week 96 ]

25.  Primary:   Viral Load   [ Time Frame: Week 108 ]

26.  Primary:   Viral Load   [ Time Frame: Week 120 ]

27.  Primary:   Viral Load   [ Time Frame: Week 132 ]

28.  Primary:   Viral Load   [ Time Frame: Week 144 ]

29.  Primary:   CD4 Cell Count   [ Time Frame: Baseline ]

30.  Primary:   CD4 Cell Count   [ Time Frame: Week 4 ]

31.  Primary:   CD4 Cell Count   [ Time Frame: Week 12 ]

32.  Primary:   CD4 Cell Count   [ Time Frame: Week 24 ]

33.  Primary:   CD4 Cell Count   [ Time Frame: Week 36 ]

34.  Primary:   CD4 Cell Count   [ Time Frame: Week 48 ]

35.  Primary:   CD4 Cell Count   [ Time Frame: Week 60 ]

36.  Primary:   CD4 Cell Count   [ Time Frame: Week 72 ]

37.  Primary:   CD4 Cell Count   [ Time Frame: Week 84 ]

38.  Primary:   CD4 Cell Count   [ Time Frame: Week 96 ]

39.  Primary:   CD4 Cell Count   [ Time Frame: Week 108 ]

40.  Primary:   CD4 Cell Count   [ Time Frame: Week 120 ]

41.  Primary:   CD4 Cell Count   [ Time Frame: Week 132 ]

42.  Primary:   CD4 Cell Count   [ Time Frame: Week 144 ]


  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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  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: Abbott
ClinicalTrials.gov Identifier: NCT01153269     History of Changes
Other Study ID Numbers: KAL 1 HO
Study First Received: February 26, 2010
Results First Received: November 16, 2011
Last Updated: November 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices