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Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet

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ClinicalTrials.gov Identifier: NCT01097655
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus
Enrollment 3049
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description HIV-infected participants starting with Kaletra tablets.
Period Title: Overall Study
Started 3049
Completed 3039 [1]
Not Completed 10
Reason Not Completed
Withdrawal by Subject             1
Subject Documented Twice             1
Did Not Meet Inclusion Criteria             8
[1]
participants included for analysis
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description HIV-infected participants starting with Kaletra tablets.
Overall Number of Baseline Participants 3039
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2896 participants
40.7  (10.1)
[1]
Measure Analysis Population Description: participants with age recorded at Baseline
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3039 participants
Female
595
  19.6%
Male
2444
  80.4%
1.Primary Outcome
Title Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Hide Description Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
Time Frame Baseline (Week 0) to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants starting with Kaletra tablets.
Overall Number of Participants Analyzed 2981
Mean (Standard Deviation)
Unit of Measure: cells/μL
Change at Week 4 Number Analyzed 2378 participants
99.8  (145.2)
Change at Week 12 Number Analyzed 2391 participants
133.3  (148.7)
Change at Week 24 Number Analyzed 2240 participants
160.5  (177.6)
Change at Week 36 Number Analyzed 2004 participants
185.9  (181.2)
Change at Week 48 Number Analyzed 1867 participants
213.6  (225.1)
Change at Week 60 Number Analyzed 1694 participants
228.4  (204.6)
Change at Week 72 Number Analyzed 1545 participants
250.1  (205.1)
Change at Week 84 Number Analyzed 1370 participants
263.8  (214.8)
Change at Week 96 Number Analyzed 1340 participants
276.3  (212.8)
Change at Week 108 Number Analyzed 1222 participants
291.0  (247.6)
Change at Week 120 Number Analyzed 1171 participants
294.3  (216.5)
Change at Week 132 Number Analyzed 1110 participants
303.8  (229.3)
Change at Week 144 Number Analyzed 1173 participants
316.1  (228.2)
2.Primary Outcome
Title Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Hide Description Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.
Time Frame Baseline (Week 0) to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants starting with Kaletra tablets.
Overall Number of Participants Analyzed 2959
Mean (Standard Deviation)
Unit of Measure: log copies/mL
Change at Week 4 Number Analyzed 2323 participants
-1.90  (0.97)
Change at Week 12 Number Analyzed 2296 participants
-2.53  (1.23)
Change at Week 24 Number Analyzed 2089 participants
-2.83  (1.35)
Change at Week 36 Number Analyzed 1821 participants
-2.89  (1.40)
Change at Week 48 Number Analyzed 1693 participants
-2.89  (1.41)
Change at Week 60 Number Analyzed 1532 participants
-2.93  (1.38)
Change at Week 72 Number Analyzed 1377 participants
-2.92  (1.36)
Change at Week 84 Number Analyzed 1230 participants
-2.92  (1.37)
Change at Week 96 Number Analyzed 1198 participants
-2.93  (1.38)
Change at Week 108 Number Analyzed 1093 participants
-2.93  (1.39)
Change at Week 120 Number Analyzed 1070 participants
-2.92  (1.36)
Change at Week 132 Number Analyzed 999 participants
-2.94  (1.36)
Change at Week 144 Number Analyzed 1049 participants
-2.97  (1.34)
3.Other Pre-specified Outcome
Title Prevalence of Adverse Events (Weeks 0-144), Per Event
Hide Description Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
Time Frame Weeks 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants starting with Kaletra tablets.
Overall Number of Participants Analyzed 3039
Overall Number of Units Analyzed
Type of Units Analyzed: Adverse Events
44499
Measure Type: Number
Unit of Measure: percentage of adverse events
Hypertriglyceridemia 12.4
Hypercholesterolemia 19.3
Low HDL Cholesterol 0.5
High LDL Cholesterol 2.3
Hyperglycemia 3.0
Hyperbilirubinemia 2.7
Elevated AST 3.5
Elevated ALT 4.1
Elevated γGT 7.3
Elevated Alkaline Phosphatase 3.1
Stomatitis 0.6
Nausea 4.2
Vomiting 1.5
Diarrhea 18.3
Abdominal Pain 2.9
Mood Disorder 5.0
Neurocerebellar Disorder 0.6
Neurocontrol Disorder 0.0
Headache 1.9
Fatigue 4.0
Fever 1.4
Not Specified 4.8
4.Other Pre-specified Outcome
Title Prevalence of Adverse Events (Weeks 0-144), Per Participant
Hide Description Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
Time Frame Weeks 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants starting with Kaletra tablets.
Overall Number of Participants Analyzed 3039
Measure Type: Number
Unit of Measure: percentage of participants
Hypertriglyceridemia 14.1
Hypercholesterolemia 16.3
Low HDL Cholesterol 1.6
High LDL Cholesterol 4.0
Hyperglycemia 5.8
Hyperbilirubinemia 3.9
Elevated AST 6.7
Elevated ALT 7.5
Elevated γGT 9.3
Elevated Alkaline Phosphatase 4.7
Stomatitis 2.0
Nausea 11.5
Vomiting 4.6
Diarrhea 32.7
Abdominal Pain 8.0
Mood Disorder 9.0
Neurocerebellar Disorder 1.7
Neurocontrol Disorder 0.0
Headache 5.2
Fatigue 8.7
Fever 4.4
Not Specified 30.4
Time Frame Through Week 144
Adverse Event Reporting Description Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 3 and 4 for these data.
 
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description HIV-infected participants starting with Kaletra tablets.
All-Cause Mortality
HIV-infected Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIV-infected Participants
Affected / at Risk (%)
Total   79/3039 (2.60%) 
Blood and lymphatic system disorders   
ANAEMIA * 1  3/3039 (0.10%) 
EOSINOPHILIA * 1  1/3039 (0.03%) 
HAEMOLYTIC ANAEMIA * 1  1/3039 (0.03%) 
LYMPHADENITIS * 1  1/3039 (0.03%) 
LYMPHADENOPATHY * 1  1/3039 (0.03%) 
MACROCYTOSIS * 1  1/3039 (0.03%) 
PANCYTOPENIA * 1  2/3039 (0.07%) 
PLASMACYTOSIS * 1  1/3039 (0.03%) 
THROMBOCYTOPENIA * 1  1/3039 (0.03%) 
Cardiac disorders   
ANGINA PECTORIS * 1  1/3039 (0.03%) 
ARTERIOSCLEROSIS CORONARY ARTERY * 1  1/3039 (0.03%) 
ATRIOVENTRICULAR BLOCK * 1  1/3039 (0.03%) 
ATRIOVENTRICULAR BLOCK SECOND DEGREE * 1  1/3039 (0.03%) 
ATRIOVENTRICULAR DISSOCIATION * 1  1/3039 (0.03%) 
BRADYCARDIA * 1  1/3039 (0.03%) 
BUNDLE BRANCH BLOCK RIGHT * 1  1/3039 (0.03%) 
CARDIAC VALVE DISEASE * 1  1/3039 (0.03%) 
DEGENERATIVE MITRAL VALVE DISEASE * 1  1/3039 (0.03%) 
EXTRASYSTOLES * 1  1/3039 (0.03%) 
MYOCARDIAL INFARCTION * 1  2/3039 (0.07%) 
PLEUROPERICARDITIS * 1  1/3039 (0.03%) 
RIGHT VENTRICULAR FAILURE * 1  1/3039 (0.03%) 
VENTRICULAR TACHYCARDIA * 1  1/3039 (0.03%) 
Endocrine disorders   
HYPERTHYROIDISM * 1  1/3039 (0.03%) 
Eye disorders   
EYE SWELLING * 1  1/3039 (0.03%) 
Gastrointestinal disorders   
ABDOMINAL HERNIA * 1  1/3039 (0.03%) 
ABDOMINAL PAIN * 1  5/3039 (0.16%) 
ALCOHOLIC PANCREATITIS * 1  1/3039 (0.03%) 
ANAL FISTULA * 1  2/3039 (0.07%) 
ASCITES * 1  1/3039 (0.03%) 
CHRONIC GASTRITIS * 1  1/3039 (0.03%) 
DIARRHOEA * 1  6/3039 (0.20%) 
DIARRHOEA HAEMORRHAGIC * 1  1/3039 (0.03%) 
DYSPHAGIA * 1  1/3039 (0.03%) 
GASTROINTESTINAL DISORDER * 1  1/3039 (0.03%) 
GINGIVITIS ULCERATIVE * 1  1/3039 (0.03%) 
HAEMATEMESIS * 1  1/3039 (0.03%) 
HAEMORRHOIDS * 1  2/3039 (0.07%) 
INGUINAL HERNIA * 1  2/3039 (0.07%) 
LEUKOPLAKIA ORAL * 1  1/3039 (0.03%) 
NAUSEA * 1  4/3039 (0.13%) 
OESOPHAGITIS * 1  1/3039 (0.03%) 
PANCREATIC CYST * 1  1/3039 (0.03%) 
PANCREATITIS * 1  1/3039 (0.03%) 
PROCTALGIA * 1  1/3039 (0.03%) 
SALIVARY GLAND CYST * 1  1/3039 (0.03%) 
VOMITING * 1  3/3039 (0.10%) 
General disorders   
ASTHENIA * 1  1/3039 (0.03%) 
CHEST PAIN * 1  1/3039 (0.03%) 
CHILLS * 1  1/3039 (0.03%) 
DRUG INTOLERANCE * 1  1/3039 (0.03%) 
DRUG WITHDRAWAL SYNDROME * 1  1/3039 (0.03%) 
GENERAL PHYSICAL HEALTH DETERIORATION * 1  4/3039 (0.13%) 
PAIN * 1  3/3039 (0.10%) 
PYREXIA * 1  5/3039 (0.16%) 
Hepatobiliary disorders   
HEPATIC CIRRHOSIS * 1  1/3039 (0.03%) 
HEPATIC LESION * 1  1/3039 (0.03%) 
Immune system disorders   
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME * 1  2/3039 (0.07%) 
Infections and infestations   
AIDS DEMENTIA COMPLEX * 1  1/3039 (0.03%) 
ACQUIRED IMMUNODEFICIENCY SYNDROME * 1  1/3039 (0.03%) 
ANAL ABSCESS * 1  1/3039 (0.03%) 
CHLAMYDIAL INFECTION * 1  1/3039 (0.03%) 
CYTOMEGALOVIRUS COLITIS * 1  1/3039 (0.03%) 
ENDOCARDITIS * 1  1/3039 (0.03%) 
FUNGAL OESOPHAGITIS * 1  1/3039 (0.03%) 
GASTROENTERITIS * 1  2/3039 (0.07%) 
GASTROINTESTINAL INFECTION * 1  2/3039 (0.07%) 
HELICOBACTER GASTRITIS * 1  1/3039 (0.03%) 
HERPES VIRUS INFECTION * 1  1/3039 (0.03%) 
HERPES ZOSTER * 1  2/3039 (0.07%) 
LEISHMANIASIS * 1  1/3039 (0.03%) 
LYMPH NODE TUBERCULOSIS * 1  1/3039 (0.03%) 
LYMPHOGRANULOMA VENEREUM * 1  1/3039 (0.03%) 
MYCOBACTERIUM AVIUM COMPLEX INFECTION * 1  1/3039 (0.03%) 
OESOPHAGEAL CANDIDIASIS * 1  1/3039 (0.03%) 
OPHTHALMIC HERPES ZOSTER * 1  1/3039 (0.03%) 
ORAL CANDIDIASIS * 1  1/3039 (0.03%) 
ORAL HERPES * 1  1/3039 (0.03%) 
PNEUMOCYSTIS JIROVECII PNEUMONIA * 1  1/3039 (0.03%) 
PNEUMONIA * 1  5/3039 (0.16%) 
PULMONARY TUBERCULOSIS * 1  2/3039 (0.07%) 
SALMONELLOSIS * 1  1/3039 (0.03%) 
SECONDARY TRANSMISSION * 1  1/3039 (0.03%) 
SINUSITIS * 1  1/3039 (0.03%) 
STAPHYLOCOCCAL SEPSIS * 1  1/3039 (0.03%) 
TONSILLITIS * 1  1/3039 (0.03%) 
Injury, poisoning and procedural complications   
FALL * 1  1/3039 (0.03%) 
FEMORAL NECK FRACTURE * 1  1/3039 (0.03%) 
LUMBAR VERTEBRAL FRACTURE * 1  3/3039 (0.10%) 
Investigations   
BLOOD TRIGLYCERIDES INCREASED * 1  2/3039 (0.07%) 
CYTOMEGALOVIRUS TEST POSITIVE * 1  1/3039 (0.03%) 
GENERAL PHYSICAL CONDITION ABNORMAL * 1  1/3039 (0.03%) 
WEIGHT DECREASED * 1  1/3039 (0.03%) 
Metabolism and nutrition disorders   
DECREASED APPETITE * 1  1/3039 (0.03%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA * 1  1/3039 (0.03%) 
INGUINAL MASS * 1  1/3039 (0.03%) 
INTERVERTEBRAL DISC PROTRUSION * 1  3/3039 (0.10%) 
OSTEONECROSIS * 1  1/3039 (0.03%) 
OSTEOPOROSIS * 1  1/3039 (0.03%) 
PAIN IN EXTREMITY * 1  1/3039 (0.03%) 
SPINAL PAIN * 1  1/3039 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
ANAL CANCER * 1  1/3039 (0.03%) 
ANAPLASTIC LARGE CELL LYMPHOMA T- AND NULL-CELL TYPE STAGE IV * 1  1/3039 (0.03%) 
ANOGENITAL WARTS * 1  2/3039 (0.07%) 
BURKITT'S LYMPHOMA * 1  3/3039 (0.10%) 
EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) * 1  2/3039 (0.07%) 
HEPATIC CANCER * 1  1/3039 (0.03%) 
KAPOSI'S SARCOMA * 1  2/3039 (0.07%) 
PAPILLOMA * 1  1/3039 (0.03%) 
PLASMABLASTIC LYMPHOMA * 1  1/3039 (0.03%) 
Nervous system disorders   
ATAXIA * 1  1/3039 (0.03%) 
BALANCE DISORDER * 1  1/3039 (0.03%) 
CEREBRAL ARTERIOSCLEROSIS * 1  1/3039 (0.03%) 
CEREBRAL ATROPHY * 1  1/3039 (0.03%) 
CEREBRAL INFARCTION * 1  2/3039 (0.07%) 
DISTURBANCE IN ATTENTION * 1  1/3039 (0.03%) 
FACIAL PARESIS * 1  1/3039 (0.03%) 
HEADACHE * 1  3/3039 (0.10%) 
HYPOAESTHESIA * 1  1/3039 (0.03%) 
MEMORY IMPAIRMENT * 1  1/3039 (0.03%) 
MENINGEAL DISORDER * 1  1/3039 (0.03%) 
PARAESTHESIA * 1  1/3039 (0.03%) 
RADICULOPATHY * 1  1/3039 (0.03%) 
SOMNOLENCE * 1  1/3039 (0.03%) 
Pregnancy, puerperium and perinatal conditions   
ABORTION * 1  1/3039 (0.03%) 
ABORTION MISSED * 1  1/3039 (0.03%) 
ABORTION SPONTANEOUS * 1  3/3039 (0.10%) 
MATERNAL CONDITION AFFECTING FOETUS * 1  1/3039 (0.03%) 
PLACENTAL INSUFFICIENCY * 1  1/3039 (0.03%) 
PREMATURE BABY * 1  1/3039 (0.03%) 
Psychiatric disorders   
APATHY * 1  1/3039 (0.03%) 
CONFUSIONAL STATE * 1  1/3039 (0.03%) 
DELIRIUM * 1  1/3039 (0.03%) 
DEPRESSION * 1  1/3039 (0.03%) 
DISORIENTATION * 1  1/3039 (0.03%) 
Renal and urinary disorders   
HYDRONEPHROSIS * 1  1/3039 (0.03%) 
NEPHROLITHIASIS * 1  1/3039 (0.03%) 
NOCTURIA * 1  1/3039 (0.03%) 
RENAL CYST * 1  1/3039 (0.03%) 
RENAL FAILURE * 1  1/3039 (0.03%) 
URINARY BLADDER POLYP * 1  1/3039 (0.03%) 
Reproductive system and breast disorders   
ADENOMYOSIS * 1  1/3039 (0.03%) 
MENOMETRORRHAGIA * 1  1/3039 (0.03%) 
PROSTATIC MASS * 1  1/3039 (0.03%) 
VAGINAL HAEMORRHAGE * 1  2/3039 (0.07%) 
Respiratory, thoracic and mediastinal disorders   
CHRONIC OBSTRUCTIVE PULMONARY DISEASE * 1  1/3039 (0.03%) 
COUGH * 1  1/3039 (0.03%) 
DYSPNOEA * 1  3/3039 (0.10%) 
LUNG INFILTRATION * 1  1/3039 (0.03%) 
OROPHARYNGEAL PAIN * 1  1/3039 (0.03%) 
RALES * 1  1/3039 (0.03%) 
Surgical and medical procedures   
ABORTION INDUCED * 1  1/3039 (0.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV-infected Participants
Affected / at Risk (%)
Total   0/0 
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.
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01097655     History of Changes
Other Study ID Numbers: P06-131
First Submitted: February 26, 2010
First Posted: April 2, 2010
Results First Submitted: January 18, 2017
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017