Kaletra: Therapy With Double Protease Inhibitors

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	HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily).

Participant Flow:   Overall Study

	HIV-infected Participants
STARTED	60 [1]
Discontinued Year 1	7
Discontinued Year 2	6
Discontinued Year 3	5
COMPLETED	42
NOT COMPLETED	18
Death	1
Intensification	3
Co-morbidities	1
Adverse Event	4
Noncompliance	3
Therapy Break	3
Patient's Wish	2
Unknown Reasons	1

[1]	65 participants were enrolled; 5 protocol violations were excluded from all analyses except safety.

  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 taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily).

Baseline Measures

	HIV-infected Participants
Overall Participants Analyzed; [Units: Participants]	60
Age [1]; [Units: Years]; Mean (Standard Deviation)	44.2 (9.0)
[1] In 10 participants, age was missing.
Gender; [Units: Participants]
Female	7
Male	53
Region of Enrollment; [Units: Participants]
Germany	60

  Outcome Measures

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1. Primary:

Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]

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2. Secondary:

Change From Baseline in Absolute CD4 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]

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3. Secondary:

Change From Baseline in Relative CD4 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]

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4. Secondary:

Change From Baseline in Absolute CD8 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]

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5. Secondary:

Change From Baseline in Relative CD8 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]

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6. Secondary:

Change From Baseline in CD4/CD8 T-cell Ratio [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]

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  Serious Adverse Events

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  Other Adverse Events

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  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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

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:	NCT01075191 History of Changes
Other Study ID Numbers:	P05-103
First Submitted:	February 23, 2010
First Posted:	February 25, 2010
Results First Submitted:	September 28, 2012
Results First Posted:	October 30, 2012
Last Update Posted:	January 18, 2013