Kaletra: Therapy With Double Protease Inhibitors

Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Condition	Human Immunodeficiency Virus
Enrollment	65

Participant Flow

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Recruitment Details
Pre-assignment Details

Arm/Group Title	HIV-infected Participants
Arm/Group Description	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).
Period Title: Overall Study
Started	60 [1]
Discontinued Year 1	7
Discontinued Year 2	6
Discontinued Year 3	5
Completed	42
Not Completed	18
Reason Not Completed
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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Arm/Group Title		HIV-infected Participants
Arm/Group Description		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).
Overall Number of Baseline Participants		60
Baseline Analysis Population Description		[Not Specified]
Age Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	60 participants
		44.2 (9.0)
		[1] Measure Description: In 10 participants, age was missing.
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	60 participants
	Female	7 11.7%
	Male	53 88.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Germany	Number Analyzed	60 participants
		60

Outcome Measures

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1. Primary Outcome

Title	Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Description	Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.
Time Frame	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Outcome Measure Data

Analysis Population Description

Evaluable participants. n=number of evaluable participants with given measurement at time point.

Arm/Group Title	HIV-infected Participants
Arm/Group Description:	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).
Overall Number of Participants Analyzed	60
Measure Type: Number; Unit of Measure: percentage of participants
Baseline (n=58)	8.6
Week 4 (n=42)	26.2
Week 12 (n=50)	40.0
Week 24 (n=48)	56.3
Week 36 (n=42)	69.1
Week 48 (n=41)	65.9
Week 60 (n=38)	68.4
Week 72 (n=38)	76.3
Week 84 (n=34)	76.5
Week 96 (n=30)	56.7
Week 108 (n=34)	58.8
Week 120 (n=30)	63.3
Week 132 (n=31)	58.1
Week 144 (n=29)	69.0

2. Secondary Outcome

Title	Change From Baseline in Absolute CD4 Cell Count
Description	Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Outcome Measure Data

Analysis Population Description

Evaluable participants. n=number of evaluable participants with given measurement at time point.

Arm/Group Title	HIV-infected Participants
Arm/Group Description:	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).
Overall Number of Participants Analyzed	60
Mean (Standard Deviation); Unit of Measure: cells/µL
Baseline (n=58)	312.0 (227)
Change at Week 4 (n=44)	48.2 (134)
Change at Week 12 (n=51)	115.7 (186)
Change at Week 24 (n=48)	124.5 (176)
Change at Week 36 (n=43)	122.6 (216)
Change at Week 48 (n=42)	129.0 (247)
Change at Week 60 (n=38)	155.4 (267)
Change at Week 72 (n=38)	180.8 (200)
Change at Week 84 (n=33)	225.7 (217)
Change at Week 96 (n=30)	227.7 (210)
Change at Week 108 (n=35)	274.7 (244)
Change at Week 120 (n=30)	274.3 (284)
Change at Week 132 (n=31)	260.8 (214)
Change at Week 144 (n=28)	271.8 (232)

3. Secondary Outcome

Title	Change From Baseline in Relative CD4 Cell Count
Description	Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.
Time Frame	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Outcome Measure Data

Analysis Population Description

Evaluable participants. n=number of evaluable participants with given measurement at time point.

Arm/Group Title	HIV-infected Participants
Arm/Group Description:	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).
Overall Number of Participants Analyzed	60
Mean (Standard Deviation); Unit of Measure: percentage of cells
Baseline (n=59)	16.8 (9.4)
Change at Week 4 (n=42)	1.4 (3.3)
Change at Week 12 (n=45)	2.8 (5.2)
Change at Week 24 (n=42)	4.1 (5.6)
Change at Week 36 (n=38)	4.9 (7.0)
Change at Week 48 (n=35)	4.9 (6.7)
Change at Week 60 (n=32)	5.4 (6.2)
Change at Week 72 (n=32)	5.0 (6.4)
Change at Week 84 (n=28)	5.7 (6.4)
Change at Week 96 (n=24)	6.3 (5.3)
Change at Week 108 (n=28)	7.9 (7.4)
Change at Week 120 (n=24)	7.6 (9.0)
Change at Week 132 (n=25)	8.4 (8.9)
Change at Week 144 (n=23)	8.6 (8.0)

4. Secondary Outcome

Title	Change From Baseline in Absolute CD8 Cell Count
Description	Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.
Time Frame	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Outcome Measure Data

Analysis Population Description

Evaluable participants. n=number of evaluable participants with given measurement at time point.

Arm/Group Title	HIV-infected Participants
Arm/Group Description:	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).
Overall Number of Participants Analyzed	60
Mean (Standard Deviation); Unit of Measure: cells/µL
Baseline (n=60)	1180.8 (713)
Change at Week 4 (n=44)	109 (728)
Change at Week 12 (n=51)	195 (762)
Change at Week 24 (n=49)	66 (671)
Change at Week 36 (n=43)	-59 (774)
Change at Week 48 (n=42)	-105 (777)
Change at Week 60 (n=38)	-42 (706)
Change at Week 72 (n=38)	4 (676)
Change at Week 84 (n=33)	132 (637)
Change at Week 96 (n=30)	54 (616)
Change at Week 108 (n=35)	39 (529)
Change at Week 120 (n=30)	24 (721)
Change at Week 132 (n=31)	-57 (676)
Change at Week 144 (n=28)	-3 (644)

5. Secondary Outcome

Title	Change From Baseline in Relative CD8 Cell Count
Description	Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.
Time Frame	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Outcome Measure Data

Analysis Population Description

Evaluable participants. n=number of evaluable participants with given measurement at time point.

Arm/Group Title	HIV-infected Participants
Arm/Group Description:	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).
Overall Number of Participants Analyzed	60
Mean (Standard Deviation); Unit of Measure: percentage of cells
Baseline (n=59)	60.4 (15.0)
Change at Week 4 (n=41)	-2.2 (13.9)
Change at Week 12 (n=45)	-2.1 (15.8)
Change at Week 24 (n=42)	-7.1 (11.6)
Change at Week 36 (n=38)	-8.2 (12.1)
Change at Week 48 (n=35)	-8.6 (12.1)
Change at Week 60 (n=32)	-11.0 (9.4)
Change at Week 72 (n=31)	-10.9 (12.4)
Change at Week 84 (n=28)	-10.7 (13.3)
Change at Week 96 (n=24)	-10.0 (12.7)
Change at Week 108 (n=28)	-13.2 (13.0)
Change at Week 120 (n=24)	-11.5 (13.4)
Change at Week 132 (n=25)	-13.1 (12.8)
Change at Week 144 (n=23)	-13.5 (13.4)

6. Secondary Outcome

Title	Change From Baseline in CD4/CD8 T-cell Ratio
Description	The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.
Time Frame	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Outcome Measure Data

Analysis Population Description

Evaluable participants. n=number of evaluable participants with given measurement at time point.

Arm/Group Title	HIV-infected Participants
Arm/Group Description:	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).
Overall Number of Participants Analyzed	60
Mean (Standard Deviation); Unit of Measure: ratio
Baseline (n=60)	0.3 (0.2)
Change at Week 4 (n=44)	0.1 (0.1)
Change at Week 12 (n=51)	0.1 (0.2)
Change at Week 24 (n=48)	0.1 (0.2)
Change at Week 36 (n=43)	0.2 (0.3)
Change at Week 48 (n=42)	0.2 (0.3)
Change at Week 60 (n=38)	0.3 (0.3)
Change at Week 72 (n=38)	0.2 (0.3)
Change at Week 84 (n=33)	0.3 (0.3)
Change at Week 96 (n=30)	0.2 (0.2)
Change at Week 108 (n=35)	0.3 (0.3)
Change at Week 120 (n=30)	0.3 (0.3)
Change at Week 132 (n=31)	0.3 (0.3)
Change at Week 144 (n=28)	0.3 (0.4)

Adverse Events

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Time Frame	3 years
Adverse Event Reporting Description	Serious Adverse Events (SAEs) and Adverse Events (AEs) were reported by the investigators using standard reporting forms and were sent directly to the sponsor's pharmacovigilance department.
Arm/Group Title	HIV-infected Participants
Arm/Group Description	HIV-infected patients 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). Safety data presents all enrolled participants, including 5 protocol violations.
All-Cause Mortality
	HIV-infected Participants
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	HIV-infected Participants
	Affected / at Risk (%)
Total	4/65 (6.15%)
Gastrointestinal disorders
Gastroenteritis clostridial * 1	1/65 (1.54%)
Infections and infestations
Hepatitis C * 1	1/65 (1.54%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer metastatic * 1 [1]	1/65 (1.54%)
Renal and urinary disorders
Urosepsis * 1	1/65 (1.54%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 15.0; [1] leading to death
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	HIV-infected Participants
	Affected / at Risk (%)
Total	0/65 (0.00%)

Limitations and Caveats

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[Not Specified]

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.

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