Trial Outcomes & Findings for Evaluation of Kaletra Therapy Over the Long-term (NCT NCT01083810)
NCT ID: NCT01083810
Last Updated: 2011-08-11
Results Overview
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
Recruitment status
COMPLETED
Target enrollment
284 participants
Primary outcome timeframe
Baseline and at any timepoint where testing is possible
Results posted on
2011-08-11
Participant Flow
These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.
Participant milestones
| Measure |
Therapy-naive
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
137
|
92
|
55
|
|
Overall Study
COMPLETED
|
72
|
47
|
35
|
|
Overall Study
NOT COMPLETED
|
65
|
45
|
20
|
Reasons for withdrawal
| Measure |
Therapy-naive
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
11
|
4
|
|
Overall Study
Adverse Event
|
15
|
11
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
4
|
|
Overall Study
Reason not reported
|
6
|
1
|
1
|
|
Overall Study
Non-compliance
|
4
|
7
|
2
|
|
Overall Study
Simplification
|
4
|
1
|
0
|
|
Overall Study
Death
|
2
|
2
|
3
|
|
Overall Study
Co-morbidities
|
1
|
0
|
0
|
|
Overall Study
Participation in study
|
1
|
0
|
0
|
|
Overall Study
Therapy break
|
1
|
2
|
2
|
|
Overall Study
Virologic failure
|
1
|
8
|
0
|
Baseline Characteristics
Evaluation of Kaletra Therapy Over the Long-term
Baseline characteristics by cohort
| Measure |
Therapy-naive
n=137 Participants
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
n=92 Participants
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
n=55 Participants
Participants infected with non-B subtypes of HIV-1.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
>= 18 years of age (exact age not reported)
|
137 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
119 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
137 participants
n=5 Participants
|
92 participants
n=7 Participants
|
55 participants
n=5 Participants
|
284 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and at any timepoint where testing is possiblePopulation: All participants with resistance testing at baseline and follow-up are presented.
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
Outcome measures
| Measure |
Therapy-naive
n=137 Participants
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
n=92 Participants
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
n=55 Participants
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Underwent resistance testing at follow-up
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
>Resistance to lopinavir/ritonavir*
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Genotypic resistance testing performed at Baseline
|
137 Participants
|
68 Participants
|
55 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Complete resistance testing results at Baseline
|
122 Participants
|
68 Participants
|
55 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
>Resistance to lopinavir/ritonavir at Baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
>Partial resistance to NRTI at Baseline
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
>Partial resistance to NNRTI at Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
>>Resistance to NRTIs
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
>>Resistance to NNRTIs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
*No baseline results avail for this participant
|
NA Participants
NA=not applicable to this subgroup.
|
1 Participants
|
NA Participants
NA=not applicable to this subgroup.
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeksPopulation: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.
Outcome measures
| Measure |
Therapy-naive
n=137 Participants
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
n=92 Participants
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
n=55 Participants
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Baseline
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 12
|
44 Percentage of participants
|
38 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 24
|
69 Percentage of participants
|
58 Percentage of participants
|
74 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 72
|
89 Percentage of participants
|
62 Percentage of participants
|
83 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 84
|
87 Percentage of participants
|
66 Percentage of participants
|
88 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 96
|
90 Percentage of participants
|
58 Percentage of participants
|
77 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 216
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
50 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 228
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
44 Percentage of participants
|
75 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 4
|
7 Percentage of participants
|
26 Percentage of participants
|
5 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 36
|
75 Percentage of participants
|
60 Percentage of participants
|
76 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 48
|
83 Percentage of participants
|
67 Percentage of participants
|
80 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 60
|
78 Percentage of participants
|
65 Percentage of participants
|
79 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 108
|
81 Percentage of participants
|
66 Percentage of participants
|
87 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 120
|
85 Percentage of participants
|
63 Percentage of participants
|
88 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 132
|
87 Percentage of participants
|
52 Percentage of participants
|
95 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 144
|
88 Percentage of participants
|
65 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 156
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
48 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 168
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
52 Percentage of participants
|
91 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 180
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
53 Percentage of participants
|
83 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 192
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
45 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 204
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
41 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Week 240
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
38 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeksPopulation: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.
Outcome measures
| Measure |
Therapy-naive
n=137 Participants
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
n=92 Participants
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
n=55 Participants
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 36
|
18 Percentage of participants
|
9 Percentage of participants
|
10 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 48
|
10 Percentage of participants
|
12 Percentage of participants
|
5 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 72
|
5 Percentage of participants
|
17 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 84
|
9 Percentage of participants
|
13 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 96
|
6 Percentage of participants
|
9 Percentage of participants
|
10 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 108
|
14 Percentage of participants
|
8 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 120
|
5 Percentage of participants
|
3 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 132
|
3 Percentage of participants
|
13 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 156
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 240
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 144
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 168
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Baseline
|
1 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 4
|
17 Percentage of participants
|
15 Percentage of participants
|
14 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 12
|
32 Percentage of participants
|
15 Percentage of participants
|
25 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 24
|
22 Percentage of participants
|
20 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 60
|
13 Percentage of participants
|
10 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 180
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
5 Percentage of participants
|
8 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 192
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 204
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 216
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
10 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Week 228
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
0 Percentage of participants
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeksPopulation: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.
Outcome measures
| Measure |
Therapy-naive
n=137 Participants
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
n=92 Participants
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
n=55 Participants
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 24
|
3 Percentage of participants
|
6 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 4
|
18 Percentage of participants
|
12 Percentage of participants
|
19 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 48
|
1 Percentage of participants
|
0 Percentage of participants
|
13 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 192
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
10 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 204
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 228
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 240
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Baseline
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 12
|
12 Percentage of participants
|
15 Percentage of participants
|
17 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 36
|
1 Percentage of participants
|
9 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 60
|
2 Percentage of participants
|
6 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 72
|
0 Percentage of participants
|
6 Percentage of participants
|
8 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 84
|
2 Percentage of participants
|
5 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 96
|
0 Percentage of participants
|
7 Percentage of participants
|
7 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 108
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 120
|
2 Percentage of participants
|
9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 132
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 144
|
0 Percentage of participants
|
10 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 216
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 156
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
10 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 168
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
10 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Week 180
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
0 Percentage of participants
|
8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeksPopulation: All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.
Outcome measures
| Measure |
Therapy-naive
n=137 Participants
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
n=92 Participants
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
n=55 Participants
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 84
|
2 Percentage of participants
|
16 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 96
|
4 Percentage of participants
|
26 Percentage of participants
|
7 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 132
|
8 Percentage of participants
|
36 Percentage of participants
|
5 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Baseline
|
99 Percentage of participants
|
89 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 4
|
59 Percentage of participants
|
46 Percentage of participants
|
63 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 12
|
13 Percentage of participants
|
32 Percentage of participants
|
15 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 24
|
6 Percentage of participants
|
17 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 36
|
6 Percentage of participants
|
23 Percentage of participants
|
8 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 48
|
6 Percentage of participants
|
21 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 60
|
7 Percentage of participants
|
18 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 72
|
5 Percentage of participants
|
15 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 108
|
5 Percentage of participants
|
26 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 120
|
7 Percentage of participants
|
26 Percentage of participants
|
8 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 144
|
13 Percentage of participants
|
26 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 156
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
43 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 168
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
38 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 180
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
42 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 192
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
40 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 204
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
53 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 216
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
40 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 228
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
50 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Week 240
|
NA Percentage of participants
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
56 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeksPopulation: All participants with CD4+ measurements at Baseline and any subsequent time point are included.
The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.
Outcome measures
| Measure |
Therapy-naive
n=137 Participants
Participants who had not received prior antiretroviral drug therapy.
|
Pre-treated
n=92 Participants
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
|
Non-B
n=55 Participants
Participants infected with non-B subtypes of HIV-1.
|
|---|---|---|---|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 12
|
146 CD4+ cells/µL
Standard Deviation 130
|
98 CD4+ cells/µL
Standard Deviation 204
|
92 CD4+ cells/µL
Standard Deviation 117
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 96
|
296 CD4+ cells/µL
Standard Deviation 190
|
192 CD4+ cells/µL
Standard Deviation 223
|
239 CD4+ cells/µL
Standard Deviation 205
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 216
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
210 CD4+ cells/µL
Standard Deviation 243
|
395 CD4+ cells/µL
Standard Deviation 230
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 228
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
208 CD4+ cells/µL
Standard Deviation 345
|
399 CD4+ cells/µL
Standard Deviation 93
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 240
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
179 CD4+ cells/µL
Standard Deviation 185
|
542 CD4+ cells/µL
Standard Deviation 188
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 156
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
220 CD4+ cells/µL
Standard Deviation 183
|
404 CD4+ cells/µL
Standard Deviation 162
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 168
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
190 CD4+ cells/µL
Standard Deviation 156
|
426 CD4+ cells/µL
Standard Deviation 189
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 180
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
174 CD4+ cells/µL
Standard Deviation 225
|
422 CD4+ cells/µL
Standard Deviation 135
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 192
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
192 CD4+ cells/µL
Standard Deviation 186
|
474 CD4+ cells/µL
Standard Deviation 162
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 204
|
NA CD4+ cells/µL
Standard Deviation NA
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
|
131 CD4+ cells/µL
Standard Deviation 244
|
420 CD4+ cells/µL
Standard Deviation 172
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Baseline
|
0 CD4+ cells/µL
Standard Deviation 0
|
0 CD4+ cells/µL
Standard Deviation 0
|
0 CD4+ cells/µL
Standard Deviation 0
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 4
|
140 CD4+ cells/µL
Standard Deviation 145
|
68 CD4+ cells/µL
Standard Deviation 122
|
131 CD4+ cells/µL
Standard Deviation 203
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 24
|
193 CD4+ cells/µL
Standard Deviation 170
|
106 CD4+ cells/µL
Standard Deviation 209
|
128 CD4+ cells/µL
Standard Deviation 139
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 36
|
211 CD4+ cells/µL
Standard Deviation 203
|
144 CD4+ cells/µL
Standard Deviation 203
|
148 CD4+ cells/µL
Standard Deviation 134
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 48
|
240 CD4+ cells/µL
Standard Deviation 162
|
114 CD4+ cells/µL
Standard Deviation 200
|
204 CD4+ cells/µL
Standard Deviation 173
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 60
|
266 CD4+ cells/µL
Standard Deviation 185
|
144 CD4+ cells/µL
Standard Deviation 196
|
222 CD4+ cells/µL
Standard Deviation 206
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 72
|
248 CD4+ cells/µL
Standard Deviation 201
|
179 CD4+ cells/µL
Standard Deviation 193
|
259 CD4+ cells/µL
Standard Deviation 204
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 84
|
295 CD4+ cells/µL
Standard Deviation 248
|
181 CD4+ cells/µL
Standard Deviation 176
|
226 CD4+ cells/µL
Standard Deviation 161
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 108
|
329 CD4+ cells/µL
Standard Deviation 204
|
223 CD4+ cells/µL
Standard Deviation 227
|
255 CD4+ cells/µL
Standard Deviation 195
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 120
|
316 CD4+ cells/µL
Standard Deviation 177
|
217 CD4+ cells/µL
Standard Deviation 206
|
275 CD4+ cells/µL
Standard Deviation 199
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 132
|
313 CD4+ cells/µL
Standard Deviation 237
|
213 CD4+ cells/µL
Standard Deviation 167
|
325 CD4+ cells/µL
Standard Deviation 218
|
|
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Week 144
|
292 CD4+ cells/µL
Standard Deviation 163
|
251 CD4+ cells/µL
Standard Deviation 244
|
320 CD4+ cells/µL
Standard Deviation 131
|
Adverse Events
HIV-infected Patients
Serious events: 16 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV-infected Patients
n=284 participants at risk
Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55).
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Gastrointestinal disorders
Nausea
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Metabolism and nutrition disorders
Weight loss
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Nervous system disorders
Ataxia left leg
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Nervous system disorders
Paralysis left upper extremity
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Nervous system disorders
Paralysis of left side of face
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Nervous system disorders
Fall
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Nervous system disorders
Stupor
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Nervous system disorders
Confusion
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Nervous system disorders
Thickening of meninges
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant lymphoma
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastases
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
3/284 • Number of events 3 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Blood and lymphatic system disorders
Lymph nodes enlarged
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Common cold
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Myobacterium avium
|
1.1%
3/284 • Number of events 3 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Myobacterium kansaii
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Pneumocystis pneumonia
|
1.4%
4/284 • Number of events 5 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Pneumonia
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Sepsis
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Tuberculosis
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Viral infection
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Mediastinitis
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Infections and infestations
Polyserositis
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Musculoskeletal and connective tissue disorders
Lumbosacral syndrome
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Psychiatric disorders
Aggression
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Renal and urinary disorders
Renal failure
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Hepatobiliary disorders
Cholestasis
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Hepatobiliary disorders
Gallstones
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Hepatobiliary disorders
Liver damage
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Hepatobiliary disorders
Icterus
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Vascular disorders
Deep venous thrombosis femoral
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Vascular disorders
Pulmonary artery thrombosis
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Investigations
Creatinine increased
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
General disorders
Peripheral edema
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
General disorders
Somnolence
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
General disorders
Night sweats
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
General disorders
Reduced general condition
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
General disorders
Shivering
|
0.35%
1/284 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
General disorders
Fever
|
0.70%
2/284 • Number of events 2 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
Other adverse events
| Measure |
HIV-infected Patients
n=284 participants at risk
Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55).
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.1%
40/284 • Number of events 42 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
16/284 • Number of events 16 • Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
|
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
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