Trial Outcomes & Findings for Kaletra: Therapy With Double Protease Inhibitors (NCT NCT01075191)
NCT ID: NCT01075191
Last Updated: 2013-01-18
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
65 participants
Primary outcome timeframe
Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Results posted on
2013-01-18
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Discontinued Year 1
|
7
|
|
Overall Study
Discontinued Year 2
|
6
|
|
Overall Study
Discontinued Year 3
|
5
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Intensification
|
3
|
|
Overall Study
Co-morbidities
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Noncompliance
|
3
|
|
Overall Study
Therapy Break
|
3
|
|
Overall Study
Patient's Wish
|
2
|
|
Overall Study
Unknown Reasons
|
1
|
Baseline Characteristics
Kaletra: Therapy With Double Protease Inhibitors
Baseline characteristics by cohort
| Measure |
HIV-infected Participants
n=60 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).
|
|---|---|
|
Age Continuous
|
44.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
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.
Outcome measures
| Measure |
HIV-infected Participants
n=60 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).
|
|---|---|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Baseline (n=58)
|
8.6 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 4 (n=42)
|
26.2 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 12 (n=50)
|
40.0 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 24 (n=48)
|
56.3 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 36 (n=42)
|
69.1 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 48 (n=41)
|
65.9 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 60 (n=38)
|
68.4 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 72 (n=38)
|
76.3 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 84 (n=34)
|
76.5 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 96 (n=30)
|
56.7 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 108 (n=34)
|
58.8 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 120 (n=30)
|
63.3 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 132 (n=31)
|
58.1 percentage of participants
|
|
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Week 144 (n=29)
|
69.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
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.
Outcome measures
| Measure |
HIV-infected Participants
n=60 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).
|
|---|---|
|
Change From Baseline in Absolute CD4 Cell Count
Baseline (n=58)
|
312.0 cells/µL
Standard Deviation 227
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 4 (n=44)
|
48.2 cells/µL
Standard Deviation 134
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 12 (n=51)
|
115.7 cells/µL
Standard Deviation 186
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 24 (n=48)
|
124.5 cells/µL
Standard Deviation 176
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 36 (n=43)
|
122.6 cells/µL
Standard Deviation 216
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 48 (n=42)
|
129.0 cells/µL
Standard Deviation 247
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 60 (n=38)
|
155.4 cells/µL
Standard Deviation 267
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 72 (n=38)
|
180.8 cells/µL
Standard Deviation 200
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 84 (n=33)
|
225.7 cells/µL
Standard Deviation 217
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 96 (n=30)
|
227.7 cells/µL
Standard Deviation 210
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 108 (n=35)
|
274.7 cells/µL
Standard Deviation 244
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 132 (n=31)
|
260.8 cells/µL
Standard Deviation 214
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 144 (n=28)
|
271.8 cells/µL
Standard Deviation 232
|
|
Change From Baseline in Absolute CD4 Cell Count
Change at Week 120 (n=30)
|
274.3 cells/µL
Standard Deviation 284
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
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.
Outcome measures
| Measure |
HIV-infected Participants
n=60 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).
|
|---|---|
|
Change From Baseline in Relative CD4 Cell Count
Baseline (n=59)
|
16.8 percentage of cells
Standard Deviation 9.4
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 4 (n=42)
|
1.4 percentage of cells
Standard Deviation 3.3
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 12 (n=45)
|
2.8 percentage of cells
Standard Deviation 5.2
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 24 (n=42)
|
4.1 percentage of cells
Standard Deviation 5.6
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 36 (n=38)
|
4.9 percentage of cells
Standard Deviation 7.0
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 48 (n=35)
|
4.9 percentage of cells
Standard Deviation 6.7
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 60 (n=32)
|
5.4 percentage of cells
Standard Deviation 6.2
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 72 (n=32)
|
5.0 percentage of cells
Standard Deviation 6.4
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 84 (n=28)
|
5.7 percentage of cells
Standard Deviation 6.4
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 96 (n=24)
|
6.3 percentage of cells
Standard Deviation 5.3
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 108 (n=28)
|
7.9 percentage of cells
Standard Deviation 7.4
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 120 (n=24)
|
7.6 percentage of cells
Standard Deviation 9.0
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 132 (n=25)
|
8.4 percentage of cells
Standard Deviation 8.9
|
|
Change From Baseline in Relative CD4 Cell Count
Change at Week 144 (n=23)
|
8.6 percentage of cells
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
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.
Outcome measures
| Measure |
HIV-infected Participants
n=60 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).
|
|---|---|
|
Change From Baseline in Absolute CD8 Cell Count
Baseline (n=60)
|
1180.8 cells/µL
Standard Deviation 713
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 4 (n=44)
|
109 cells/µL
Standard Deviation 728
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 12 (n=51)
|
195 cells/µL
Standard Deviation 762
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 24 (n=49)
|
66 cells/µL
Standard Deviation 671
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 36 (n=43)
|
-59 cells/µL
Standard Deviation 774
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 48 (n=42)
|
-105 cells/µL
Standard Deviation 777
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 60 (n=38)
|
-42 cells/µL
Standard Deviation 706
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 72 (n=38)
|
4 cells/µL
Standard Deviation 676
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 84 (n=33)
|
132 cells/µL
Standard Deviation 637
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 96 (n=30)
|
54 cells/µL
Standard Deviation 616
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 108 (n=35)
|
39 cells/µL
Standard Deviation 529
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 120 (n=30)
|
24 cells/µL
Standard Deviation 721
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 132 (n=31)
|
-57 cells/µL
Standard Deviation 676
|
|
Change From Baseline in Absolute CD8 Cell Count
Change at Week 144 (n=28)
|
-3 cells/µL
Standard Deviation 644
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
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.
Outcome measures
| Measure |
HIV-infected Participants
n=60 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).
|
|---|---|
|
Change From Baseline in Relative CD8 Cell Count
Baseline (n=59)
|
60.4 percentage of cells
Standard Deviation 15.0
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 4 (n=41)
|
-2.2 percentage of cells
Standard Deviation 13.9
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 12 (n=45)
|
-2.1 percentage of cells
Standard Deviation 15.8
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 24 (n=42)
|
-7.1 percentage of cells
Standard Deviation 11.6
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 36 (n=38)
|
-8.2 percentage of cells
Standard Deviation 12.1
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 48 (n=35)
|
-8.6 percentage of cells
Standard Deviation 12.1
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 60 (n=32)
|
-11.0 percentage of cells
Standard Deviation 9.4
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 72 (n=31)
|
-10.9 percentage of cells
Standard Deviation 12.4
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 84 (n=28)
|
-10.7 percentage of cells
Standard Deviation 13.3
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 96 (n=24)
|
-10.0 percentage of cells
Standard Deviation 12.7
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 108 (n=28)
|
-13.2 percentage of cells
Standard Deviation 13.0
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 120 (n=24)
|
-11.5 percentage of cells
Standard Deviation 13.4
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 132 (n=25)
|
-13.1 percentage of cells
Standard Deviation 12.8
|
|
Change From Baseline in Relative CD8 Cell Count
Change at Week 144 (n=23)
|
-13.5 percentage of cells
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
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.
Outcome measures
| Measure |
HIV-infected Participants
n=60 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).
|
|---|---|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Baseline (n=60)
|
0.3 ratio
Standard Deviation 0.2
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 4 (n=44)
|
0.1 ratio
Standard Deviation 0.1
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 12 (n=51)
|
0.1 ratio
Standard Deviation 0.2
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 24 (n=48)
|
0.1 ratio
Standard Deviation 0.2
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 36 (n=43)
|
0.2 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 48 (n=42)
|
0.2 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 60 (n=38)
|
0.3 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 72 (n=38)
|
0.2 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 84 (n=33)
|
0.3 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 96 (n=30)
|
0.2 ratio
Standard Deviation 0.2
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 108 (n=35)
|
0.3 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 120 (n=30)
|
0.3 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 132 (n=31)
|
0.3 ratio
Standard Deviation 0.3
|
|
Change From Baseline in CD4/CD8 T-cell Ratio
Change at Week 144 (n=28)
|
0.3 ratio
Standard Deviation 0.4
|
Adverse Events
HIV-infected Participants
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV-infected Participants
n=65 participants at risk
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.
|
|---|---|
|
Renal and urinary disorders
Urosepsis
|
1.5%
1/65 • 3 years
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.
|
|
Gastrointestinal disorders
Gastroenteritis clostridial
|
1.5%
1/65 • 3 years
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.
|
|
Infections and infestations
Hepatitis C
|
1.5%
1/65 • 3 years
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer metastatic
|
1.5%
1/65 • 3 years
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER