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Trial record 8 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

Evaluation of Kaletra Therapy Over the Long-term

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ClinicalTrials.gov Identifier: NCT01083810
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : July 29, 2011
Last Update Posted : August 11, 2011
Sponsor:
Information provided by:
Abbott

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus
Intervention Drug: Lopinavir/Ritonavir (Kaletra)
Enrollment 284
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Therapy-naive Pre-treated Non-B
Hide Arm/Group Description Participants who had not received prior antiretroviral drug therapy. Participants that had previously received antiretroviral therapy, but were protease inhibitor naive. Participants infected with non-B subtypes of HIV-1.
Period Title: Overall Study
Started 137 92 55
Completed 72 47 35
Not Completed 65 45 20
Reason Not Completed
Lost to Follow-up             23             11             4
Adverse Event             15             11             4
Withdrawal by Subject             7             2             4
Reason not reported             6             1             1
Non-compliance             4             7             2
Simplification             4             1             0
Death             2             2             3
Co-morbidities             1             0             0
Participation in study             1             0             0
Therapy break             1             2             2
Virologic failure             1             8             0
Arm/Group Title Therapy-naive Pre-treated Non-B Total
Hide Arm/Group Description Participants who had not received prior antiretroviral drug therapy. Participants that had previously received antiretroviral therapy, but were protease inhibitor naive. Participants infected with non-B subtypes of HIV-1. Total of all reporting groups
Overall Number of Baseline Participants 137 92 55 284
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>= 18 years of age (exact age not reported) Number Analyzed 137 participants 92 participants 55 participants 284 participants
137 92 55 284
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 137 participants 92 participants 55 participants 284 participants
Female 17 11 20 48
Male 119 81 35 235
Gender not reported 1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 137 participants 92 participants 55 participants 284 participants
137 92 55 284
1.Primary Outcome
Title Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Hide Description 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.
Time Frame Baseline and at any timepoint where testing is possible
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with resistance testing at baseline and follow-up are presented.
Arm/Group Title Therapy-naive Pre-treated Non-B
Hide Arm/Group Description:
Participants who had not received prior antiretroviral drug therapy.
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Participants infected with non-B subtypes of HIV-1.
Overall Number of Participants Analyzed 137 92 55
Measure Type: Number
Unit of Measure: Participants
Genotypic resistance testing performed at Baseline 137 68 55
Complete resistance testing results at Baseline 122 68 55
>Resistance to lopinavir/ritonavir at Baseline 0 2 0
>Partial resistance to NRTI at Baseline 5 0 0
>Partial resistance to NNRTI at Baseline 0 0 0
Underwent resistance testing at follow-up 2 2 2
>Resistance to lopinavir/ritonavir* 0 1 0
>>Resistance to NRTIs 0 1 0
>>Resistance to NNRTIs 0 0 0
*No baseline results avail for this participant NA [1]  1 NA [1] 
[1]
NA=not applicable to this subgroup.
2.Secondary Outcome
Title Percentage of Patients With HIV-1 RNA <50 Copies/ml
Hide Description 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.
Time Frame Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
Arm/Group Title Therapy-naive Pre-treated Non-B
Hide Arm/Group Description:
Participants who had not received prior antiretroviral drug therapy.
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Participants infected with non-B subtypes of HIV-1.
Overall Number of Participants Analyzed 137 92 55
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 0 3 0
Week 4 7 26 5
Week 12 44 38 42
Week 24 69 58 74
Week 36 75 60 76
Week 48 83 67 80
Week 60 78 65 79
Week 72 89 62 83
Week 84 87 66 88
Week 96 90 58 77
Week 108 81 66 87
Week 120 85 63 88
Week 132 87 52 95
Week 144 88 65 100
Week 156 NA [1]  48 100
Week 168 NA [1]  52 91
Week 180 NA [1]  53 83
Week 192 NA [1]  45 100
Week 204 NA [1]  41 100
Week 216 NA [1]  50 100
Week 228 NA [1]  44 75
Week 240 NA [1]  38 100
[1]
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
3.Secondary Outcome
Title Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Hide Description 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.
Time Frame Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
Arm/Group Title Therapy-naive Pre-treated Non-B
Hide Arm/Group Description:
Participants who had not received prior antiretroviral drug therapy.
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Participants infected with non-B subtypes of HIV-1.
Overall Number of Participants Analyzed 137 92 55
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 1 5 0
Week 4 17 15 14
Week 12 32 15 25
Week 24 22 20 18
Week 36 18 9 10
Week 48 10 12 5
Week 60 13 10 6
Week 72 5 17 3
Week 84 9 13 6
Week 96 6 9 10
Week 108 14 8 4
Week 120 5 3 4
Week 132 3 13 0
Week 144 0 0 0
Week 156 NA [1]  0 0
Week 168 NA [1]  0 0
Week 180 NA [1]  5 8
Week 192 NA [1]  5 0
Week 204 NA [1]  6 0
Week 216 NA [1]  10 0
Week 228 NA [1]  0 25
Week 240 NA [1]  0 0
[1]
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
4.Secondary Outcome
Title Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Hide Description 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.
Time Frame Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
Arm/Group Title Therapy-naive Pre-treated Non-B
Hide Arm/Group Description:
Participants who had not received prior antiretroviral drug therapy.
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Participants infected with non-B subtypes of HIV-1.
Overall Number of Participants Analyzed 137 92 55
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 0 3 0
Week 4 18 12 19
Week 12 12 15 17
Week 24 3 6 4
Week 36 1 9 6
Week 48 1 0 13
Week 60 2 6 9
Week 72 0 6 8
Week 84 2 5 3
Week 96 0 7 7
Week 108 0 0 0
Week 120 2 9 0
Week 132 3 0 0
Week 144 0 10 0
Week 156 NA [1]  10 0
Week 168 NA [1]  10 0
Week 180 NA [1]  0 8
Week 192 NA [1]  10 0
Week 204 NA [1]  0 0
Week 216 NA [1]  0 0
Week 228 NA [1]  6 0
Week 240 NA [1]  6 0
[1]
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
5.Secondary Outcome
Title Percentage of Patients With HIV-1 RNA >500 Copies/ml
Hide Description 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.
Time Frame Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.
Arm/Group Title Therapy-naive Pre-treated Non-B
Hide Arm/Group Description:
Participants who had not received prior antiretroviral drug therapy.
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Participants infected with non-B subtypes of HIV-1.
Overall Number of Participants Analyzed 137 92 55
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 99 89 100
Week 4 59 46 63
Week 12 13 32 15
Week 24 6 17 4
Week 36 6 23 8
Week 48 6 21 3
Week 60 7 18 6
Week 72 5 15 6
Week 84 2 16 3
Week 96 4 26 7
Week 108 5 26 9
Week 120 7 26 8
Week 132 8 36 5
Week 144 13 26 0
Week 156 NA [1]  43 0
Week 168 NA [1]  38 9
Week 180 NA [1]  42 0
Week 192 NA [1]  40 0
Week 204 NA [1]  53 0
Week 216 NA [1]  40 0
Week 228 NA [1]  50 0
Week 240 NA [1]  56 0
[1]
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
6.Secondary Outcome
Title Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Hide Description 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.
Time Frame Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ measurements at Baseline and any subsequent time point are included.
Arm/Group Title Therapy-naive Pre-treated Non-B
Hide Arm/Group Description:
Participants who had not received prior antiretroviral drug therapy.
Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Participants infected with non-B subtypes of HIV-1.
Overall Number of Participants Analyzed 137 92 55
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/µL
Baseline 0  (0) 0  (0) 0  (0)
Week 4 140  (145) 68  (122) 131  (203)
Week 12 146  (130) 98  (204) 92  (117)
Week 24 193  (170) 106  (209) 128  (139)
Week 36 211  (203) 144  (203) 148  (134)
Week 48 240  (162) 114  (200) 204  (173)
Week 60 266  (185) 144  (196) 222  (206)
Week 72 248  (201) 179  (193) 259  (204)
Week 84 295  (248) 181  (176) 226  (161)
Week 96 296  (190) 192  (223) 239  (205)
Week 108 329  (204) 223  (227) 255  (195)
Week 120 316  (177) 217  (206) 275  (199)
Week 132 313  (237) 213  (167) 325  (218)
Week 144 292  (163) 251  (244) 320  (131)
Week 156 NA [1]   (NA) 220  (183) 404  (162)
Week 168 NA [1]   (NA) 190  (156) 426  (189)
Week 180 NA [1]   (NA) 174  (225) 422  (135)
Week 192 NA [1]   (NA) 192  (186) 474  (162)
Week 204 NA [1]   (NA) 131  (244) 420  (172)
Week 216 NA [1]   (NA) 210  (243) 395  (230)
Week 228 NA [1]   (NA) 208  (345) 399  (93)
Week 240 NA [1]   (NA) 179  (185) 542  (188)
[1]
Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.
Time Frame Investigators were instructed to report adverse events throughout the study (up to 5 years).
Adverse Event Reporting Description 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.
 
Arm/Group Title HIV-infected Patients
Hide Arm/Group Description 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).
All-Cause Mortality
HIV-infected Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HIV-infected Patients
Affected / at Risk (%) # Events
Total   16/284 (5.63%)    
Blood and lymphatic system disorders   
Anemia * 1  3/284 (1.06%)  3
Lymph nodes enlarged * 1  1/284 (0.35%)  1
Gastrointestinal disorders   
Diarrhea * 1  2/284 (0.70%)  2
Nausea * 1  1/284 (0.35%)  1
Vomiting * 1  1/284 (0.35%)  1
General disorders   
Peripheral edema * 1  1/284 (0.35%)  1
Somnolence * 1  2/284 (0.70%)  2
Night sweats * 1  2/284 (0.70%)  2
Reduced general condition * 1  1/284 (0.35%)  1
Shivering * 1  1/284 (0.35%)  1
Fever * 1  2/284 (0.70%)  2
Hepatobiliary disorders   
Cholestasis * 1  1/284 (0.35%)  1
Gallstones * 1  1/284 (0.35%)  1
Liver damage * 1  1/284 (0.35%)  1
Icterus * 1  1/284 (0.35%)  1
Infections and infestations   
Common cold * 1  1/284 (0.35%)  1
Cerebral toxoplasmosis * 1  1/284 (0.35%)  1
Myobacterium avium * 1  3/284 (1.06%)  3
Myobacterium kansaii * 1  1/284 (0.35%)  1
Pneumocystis pneumonia * 1  4/284 (1.41%)  5
Pneumonia * 1  2/284 (0.70%)  2
Sepsis * 1  2/284 (0.70%)  2
Tuberculosis * 1  2/284 (0.70%)  2
Viral infection * 1  1/284 (0.35%)  1
Mediastinitis * 1  1/284 (0.35%)  1
Polyserositis * 1  1/284 (0.35%)  1
Investigations   
Creatinine increased * 1  1/284 (0.35%)  1
Metabolism and nutrition disorders   
Weight loss * 1  1/284 (0.35%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/284 (0.35%)  1
Lumbosacral syndrome * 1  1/284 (0.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bronchial carcinoma * 1  1/284 (0.35%)  1
Lung carcinoma * 1  1/284 (0.35%)  1
Malignant lymphoma * 1  1/284 (0.35%)  1
Non-Hodgkin's lymphoma * 1  1/284 (0.35%)  1
Brain metastases * 1  1/284 (0.35%)  1
Nervous system disorders   
Ataxia left leg * 1  1/284 (0.35%)  1
Paralysis left upper extremity * 1  1/284 (0.35%)  1
Paralysis of left side of face * 1  1/284 (0.35%)  1
Fall * 1  1/284 (0.35%)  1
Stupor * 1  1/284 (0.35%)  1
Confusion * 1  1/284 (0.35%)  1
Thickening of meninges * 1  1/284 (0.35%)  1
Psychiatric disorders   
Aggression * 1  1/284 (0.35%)  1
Renal and urinary disorders   
Renal failure * 1  2/284 (0.70%)  2
Vascular disorders   
Deep venous thrombosis femoral * 1  1/284 (0.35%)  1
Pulmonary artery thrombosis * 1  1/284 (0.35%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Raw (uncoded) terms
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIV-infected Patients
Affected / at Risk (%) # Events
Total   56/284 (19.72%)    
Gastrointestinal disorders   
Diarrhea * 1  40/284 (14.08%)  42
Nausea * 1  16/284 (5.63%)  16
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Raw (uncoded) terms
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Layout table for additonal information
Responsible Party: Dr. Stefan Simianer, Medical Director, Medical Department, Abbott Germany (Wiesbaden)
ClinicalTrials.gov Identifier: NCT01083810     History of Changes
Obsolete Identifiers: NCT01081470, NCT01083836
Other Study ID Numbers: KAL 1 RO
First Submitted: February 26, 2010
First Posted: March 10, 2010
Results First Submitted: June 30, 2011
Results First Posted: July 29, 2011
Last Update Posted: August 11, 2011