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Kaletra in Combination With Antiretroviral Agents (PROTEKT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01076179
First received: February 24, 2010
Last updated: May 18, 2017
Last verified: May 2017
Results First Received: January 18, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus

  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 Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists

Participant Flow:   Overall Study
    HIV-infected Participants
STARTED   502 
COMPLETED   501 
NOT COMPLETED   1 
Withdrawal by Subject                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 HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists

Baseline Measures
   HIV-infected Participants 
Overall Participants Analyzed 
[Units: Participants]
 501 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      70  14.0% 
Male      431  86.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Prevalence of Adverse Events (Weeks 0-144), Per Event   [ Time Frame: Weeks 0 to 144 ]

2.  Primary:   Prevalence of Adverse Events (Weeks 0-144), Per Participant   [ Time Frame: Weeks 0 to 144 ]

3.  Secondary:   Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count   [ Time Frame: Baseline (Week 0) to Week 144 ]

4.  Secondary:   Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis   [ Time Frame: Baseline (Week 0) to Week 144 ]

5.  Secondary:   Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis   [ Time Frame: Baseline (Week 0) to Week 144 ]

6.  Secondary:   Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL   [ Time Frame: From Week 0 to Week 144 ]

7.  Secondary:   Number of Participants With Lopinavir (LPV) Resistance at Baseline   [ Time Frame: Baseline (Week 0) ]

8.  Secondary:   Number of Participants With LPV Resistance During Follow-Up   [ Time Frame: up to Week 144 ]

9.  Secondary:   Number of Participants With Protease Inhibitor (PI) Resistance at Baseline   [ Time Frame: Baseline (Week 0) ]

10.  Secondary:   Number of Participants With PI Resistance During Follow-Up   [ Time Frame: Up to Week 144 ]

11.  Secondary:   Number of Participants With INI Resistance at Baseline   [ Time Frame: Baseline (Week 0) ]

12.  Secondary:   Number of Participants With INI Resistance During Follow-Up   [ Time Frame: up to Week 144 ]

13.  Secondary:   Number of Participants With NNRTI Resistance at Baseline   [ Time Frame: Baseline (Week 0) ]

14.  Secondary:   Number of Participants With NNRTI Resistance During Follow-Up   [ Time Frame: up to Week 144 ]

15.  Secondary:   Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline   [ Time Frame: Baseline (Week 0) ]

16.  Secondary:   Number of Participants With NRTI Resistance During Follow-Up   [ Time Frame: up to Week 144 ]

17.  Secondary:   Number of Participants With HIV-1 Coreceptor Tropism at Baseline   [ Time Frame: Baseline (Week 0) ]

18.  Secondary:   Number of Participants With HIV-1 Coreceptor Tropism During Follow-up   [ Time Frame: up to Week 144 ]

19.  Other Pre-specified:   Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load   [ Time Frame: Baseline (Week 0) to Week 144 ]

20.  Other Pre-specified:   Time to Virologic Failure   [ Time Frame: Baseline (Week 0) to 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: AbbVie (prior sponsor Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01076179     History of Changes
Other Study ID Numbers: P11-021
Study First Received: February 24, 2010
Results First Received: January 18, 2017
Last Updated: May 18, 2017