Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Drug Use Investigation of Kaletra

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01076972
First received: February 25, 2010
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: December 9, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus
Intervention: Drug: Lopinavir/ritonavir (Kaletra)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Participant Flow:   Overall Study
    Lopinavir/Ritonavir Group  
STARTED     1184  
COMPLETED     1184  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Baseline Measures
    Lopinavir/Ritonavir Group  
Number of Participants  
[units: participants]
  1184  
Age  
[units: years]
Mean ± Standard Deviation
  39.7  ± 11.0  
Age, Customized  
[units: participants]
 
<=14 years     4  
Between 15 and 64 years     1155  
>=65 years     25  
Gender  
[units: participants]
 
Female     106  
Male     1078  
Region of Enrollment  
[units: participants]
 
Japan     1184  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Number of Patients With Adverse Drug Reactions   [ Time Frame: During the course of the survey period up to Year 8 ]

2.  Primary:   Cluster of Differentiation 4 Lymphocyte Count (CD4)   [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

3.  Primary:   Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit   [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

4.  Primary:   Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents   [ Time Frame: Baseline (Month 0) and following last treatment dose during the course of the survey period ]


  Serious Adverse Events
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Time Frame During the course of the survey period up to Year 8.
Additional Description Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in > 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.

Reporting Groups
  Description
Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Serious Adverse Events
    Lopinavir/Ritonavir Group  
Total, serious adverse events    
# participants affected / at risk     189/1184 (15.96%)  
Blood and lymphatic system disorders    
Anaemia * 1  
# participants affected / at risk     13/1184 (1.10%)  
Disseminated intravascular coagulation * 1  
# participants affected / at risk     2/1184 (0.17%)  
Febrile neutropenia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Iron deficiency anaemia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Leukopenia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Lymphadenitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Neutropenia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pancytopenia * 1  
# participants affected / at risk     5/1184 (0.42%)  
Thrombocytopenia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Thrombocytopenic purpura * 1  
# participants affected / at risk     1/1184 (0.08%)  
Bone marrow failure * 1  
# participants affected / at risk     1/1184 (0.08%)  
Cardiac disorders    
Acute myocardial infarction * 1  
# participants affected / at risk     1/1184 (0.08%)  
Arrhythmia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Atrioventricular block * 1  
# participants affected / at risk     1/1184 (0.08%)  
Atrioventricular block complete * 1  
# participants affected / at risk     1/1184 (0.08%)  
Bradycardia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Cardiac failure * 1  
# participants affected / at risk     2/1184 (0.17%)  
Cardiac failure congestive * 1  
# participants affected / at risk     1/1184 (0.08%)  
Conduction disorder * 1  
# participants affected / at risk     1/1184 (0.08%)  
Left ventricular failure * 1  
# participants affected / at risk     1/1184 (0.08%)  
Myocardial infarction * 1  
# participants affected / at risk     2/1184 (0.17%)  
Myocarditis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Palpitations * 1  
# participants affected / at risk     2/1184 (0.17%)  
Sinus arrest * 1  
# participants affected / at risk     1/1184 (0.08%)  
Sinus bradycardia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Tachycardia * 1  
# participants affected / at risk     2/1184 (0.17%)  
Congenital, familial and genetic disorders    
Fanconi syndrome * 1  
# participants affected / at risk     1/1184 (0.08%)  
Endocrine disorders    
Adrenal insufficiency * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hyperthyroidism * 1  
# participants affected / at risk     1/1184 (0.08%)  
Eye disorders    
Cataract * 1  
# participants affected / at risk     1/1184 (0.08%)  
Retinal detachment * 1  
# participants affected / at risk     1/1184 (0.08%)  
Ulcerative keratitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Gastrointestinal disorders    
Acute abdomen * 1  
# participants affected / at risk     1/1184 (0.08%)  
Anorectal disorder * 1  
# participants affected / at risk     1/1184 (0.08%)  
Ascites * 1  
# participants affected / at risk     3/1184 (0.25%)  
Colitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Diarrhoea * 1  
# participants affected / at risk     3/1184 (0.25%)  
Duodenal ulcer * 1  
# participants affected / at risk     1/1184 (0.08%)  
Duodenal ulcer haemorrhage * 1  
# participants affected / at risk     1/1184 (0.08%)  
Enterocolitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Enterocolitis haemorrhagic * 1  
# participants affected / at risk     1/1184 (0.08%)  
Gastric ulcer * 1  
# participants affected / at risk     1/1184 (0.08%)  
Ileus * 1  
# participants affected / at risk     3/1184 (0.25%)  
Intestinal obstruction * 1  
# participants affected / at risk     2/1184 (0.17%)  
Nausea * 1  
# participants affected / at risk     3/1184 (0.25%)  
Pancreatitis acute * 1  
# participants affected / at risk     3/1184 (0.25%)  
Pancreatitis relapsing * 1  
# participants affected / at risk     1/1184 (0.08%)  
Vomiting * 1  
# participants affected / at risk     3/1184 (0.25%)  
Subileus * 1  
# participants affected / at risk     1/1184 (0.08%)  
General disorders    
Death * 1  
# participants affected / at risk     2/1184 (0.17%)  
Necrosis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pyrexia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hepatobiliary disorders    
Cholecystitis acute * 1  
# participants affected / at risk     3/1184 (0.25%)  
Cholelithiasis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hepatic cirrhosis * 1  
# participants affected / at risk     2/1184 (0.17%)  
Hepatic failure * 1  
# participants affected / at risk     3/1184 (0.25%)  
Hepatic function abnormal * 1  
# participants affected / at risk     3/1184 (0.25%)  
Hepatitis acute * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hepatitis fulminant * 1  
# participants affected / at risk     1/1184 (0.08%)  
Jaundice * 1  
# participants affected / at risk     2/1184 (0.17%)  
Liver disorder * 1  
# participants affected / at risk     3/1184 (0.25%)  
Immune system disorders    
Behcet's syndrome * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hypersensitivity * 1  
# participants affected / at risk     1/1184 (0.08%)  
Immune reconstitution syndrome * 1  
# participants affected / at risk     8/1184 (0.68%)  
Infections and infestations    
Acute tonsillitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Amoebic dysentery * 1  
# participants affected / at risk     1/1184 (0.08%)  
Appendicitis * 1  
# participants affected / at risk     3/1184 (0.25%)  
Bronchitis * 1  
# participants affected / at risk     2/1184 (0.17%)  
Cellulitis * 1  
# participants affected / at risk     2/1184 (0.17%)  
Cryptosporidiosis infection * 1  
# participants affected / at risk     1/1184 (0.08%)  
Cytomegalovirus infection * 1  
# participants affected / at risk     1/1184 (0.08%)  
Disseminated tuberculosis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Gastroenteritis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Gastroenteritis salmonella * 1  
# participants affected / at risk     1/1184 (0.08%)  
Genital herpes * 1  
# participants affected / at risk     1/1184 (0.08%)  
Giardiasis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hepatitis B * 1  
# participants affected / at risk     1/1184 (0.08%)  
Herpes zoster * 1  
# participants affected / at risk     10/1184 (0.84%)  
Influenza * 1  
# participants affected / at risk     1/1184 (0.08%)  
Measles * 1  
# participants affected / at risk     1/1184 (0.08%)  
Meningitis cryptococcal * 1  
# participants affected / at risk     2/1184 (0.17%)  
Meningitis herpes * 1  
# participants affected / at risk     1/1184 (0.08%)  
Neurosyphilis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Oesophageal candidiasis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Oral candidiasis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Otitis media * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pharyngitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pneumonia * 1  
# participants affected / at risk     7/1184 (0.59%)  
Pneumonia pneumococcal * 1  
# participants affected / at risk     1/1184 (0.08%)  
Progressive multifocal leukoencephalopathy * 1  
# participants affected / at risk     1/1184 (0.08%)  
Prostatic abscess * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pyelonephritis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Septic shock * 1  
# participants affected / at risk     2/1184 (0.17%)  
Tonsillitis * 1  
# participants affected / at risk     2/1184 (0.17%)  
Cytomegalovirus chorioretinitis * 1  
# participants affected / at risk     4/1184 (0.34%)  
AIDS encephalopathy * 1  
# participants affected / at risk     2/1184 (0.17%)  
Staphylococcal sepsis * 1  
# participants affected / at risk     2/1184 (0.17%)  
Cerebral toxoplasmosis * 1  
# participants affected / at risk     2/1184 (0.17%)  
Staphylococcal infection * 1  
# participants affected / at risk     1/1184 (0.08%)  
Mycobacterium avium complex infection * 1  
# participants affected / at risk     1/1184 (0.08%)  
Anogenital warts * 1  
# participants affected / at risk     2/1184 (0.17%)  
Tuberculosis gastrointestinal * 1  
# participants affected / at risk     1/1184 (0.08%)  
Atypical mycobacterial infection * 1  
# participants affected / at risk     2/1184 (0.17%)  
Hepatic amoebiasis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pneumocystis jiroveci pneumonia * 1  
# participants affected / at risk     5/1184 (0.42%)  
Extrapulmonary tuberculosis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Enterocolitis bacterial * 1  
# participants affected / at risk     1/1184 (0.08%)  
Oral herpes * 1  
# participants affected / at risk     1/1184 (0.08%)  
Injury, poisoning and procedural complications    
Femoral neck fracture * 1  
# participants affected / at risk     1/1184 (0.08%)  
Fracture * 1  
# participants affected / at risk     1/1184 (0.08%)  
Intentional overdose * 1  
# participants affected / at risk     1/1184 (0.08%)  
Spinal compression fracture * 1  
# participants affected / at risk     1/1184 (0.08%)  
Subdural haematoma * 1  
# participants affected / at risk     3/1184 (0.25%)  
Investigations    
C-reactive protein increased * 1  
# participants affected / at risk     1/1184 (0.08%)  
Chest X-ray abnormal * 1  
# participants affected / at risk     1/1184 (0.08%)  
Platelet count decreased * 1  
# participants affected / at risk     6/1184 (0.51%)  
Red blood cell count decreased * 1  
# participants affected / at risk     1/1184 (0.08%)  
White blood cell count decreased * 1  
# participants affected / at risk     4/1184 (0.34%)  
Protein urine present * 1  
# participants affected / at risk     1/1184 (0.08%)  
Transaminases increased * 1  
# participants affected / at risk     1/1184 (0.08%)  
Metabolism and nutrition disorders    
Cachexia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Dehydration * 1  
# participants affected / at risk     1/1184 (0.08%)  
Diabetes mellitus * 1  
# participants affected / at risk     3/1184 (0.25%)  
Glucose tolerance impaired * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hyperkalaemia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hyperlactacidaemia * 1  
# participants affected / at risk     4/1184 (0.34%)  
Hypoalbuminaemia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hypokalaemia * 1  
# participants affected / at risk     2/1184 (0.17%)  
Lactic acidosis * 1  
# participants affected / at risk     3/1184 (0.25%)  
Malnutrition * 1  
# participants affected / at risk     1/1184 (0.08%)  
Decreased appetite * 1  
# participants affected / at risk     1/1184 (0.08%)  
Musculoskeletal and connective tissue disorders    
Arthralgia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Osteomalacia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Osteonecrosis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pain in extremity * 1  
# participants affected / at risk     1/1184 (0.08%)  
Rhabdomyolysis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Acute myeloid leukaemia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Breast cancer recurrent * 1  
# participants affected / at risk     1/1184 (0.08%)  
Central nervous system lymphoma * 1  
# participants affected / at risk     1/1184 (0.08%)  
Gastric cancer * 1  
# participants affected / at risk     1/1184 (0.08%)  
Glioma * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hepatic neoplasm malignant * 1  
# participants affected / at risk     3/1184 (0.25%)  
Kaposi's sarcoma * 1  
# participants affected / at risk     1/1184 (0.08%)  
Lymphoma * 1  
# participants affected / at risk     2/1184 (0.17%)  
Malignant pleural effusion * 1  
# participants affected / at risk     1/1184 (0.08%)  
Metastases to lung * 1  
# participants affected / at risk     1/1184 (0.08%)  
Metastases to pleura * 1  
# participants affected / at risk     1/1184 (0.08%)  
Rectal cancer * 1  
# participants affected / at risk     1/1184 (0.08%)  
Squamous cell carcinoma * 1  
# participants affected / at risk     1/1184 (0.08%)  
Lung neoplasm malignant * 1  
# participants affected / at risk     1/1184 (0.08%)  
Large intestine carcinoma * 1  
# participants affected / at risk     1/1184 (0.08%)  
Anal cancer * 1  
# participants affected / at risk     1/1184 (0.08%)  
Nervous system disorders    
Cerebral haemorrhage * 1  
# participants affected / at risk     4/1184 (0.34%)  
Cerebral infarction * 1  
# participants affected / at risk     4/1184 (0.34%)  
Convulsion * 1  
# participants affected / at risk     5/1184 (0.42%)  
Encephalitis * 1  
# participants affected / at risk     2/1184 (0.17%)  
Epilepsy * 1  
# participants affected / at risk     3/1184 (0.25%)  
Guillain-Barre syndrome * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hemiparesis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hemiplegia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hepatic encephalopathy * 1  
# participants affected / at risk     2/1184 (0.17%)  
Hypoaesthesia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Loss of consciousness * 1  
# participants affected / at risk     3/1184 (0.25%)  
Memory impairment * 1  
# participants affected / at risk     1/1184 (0.08%)  
Myelitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Neuropathy peripheral * 1  
# participants affected / at risk     1/1184 (0.08%)  
Paralysis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Status epilepticus * 1  
# participants affected / at risk     1/1184 (0.08%)  
Subarachnoid haemorrhage * 1  
# participants affected / at risk     1/1184 (0.08%)  
Tremor * 1  
# participants affected / at risk     1/1184 (0.08%)  
VIIth nerve paralysis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Psychiatric disorders    
Anxiety * 1  
# participants affected / at risk     1/1184 (0.08%)  
Depression * 1  
# participants affected / at risk     2/1184 (0.17%)  
Eating disorder * 1  
# participants affected / at risk     1/1184 (0.08%)  
Emotional disorder * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hallucination, auditory * 1  
# participants affected / at risk     1/1184 (0.08%)  
Insomnia * 1  
# participants affected / at risk     2/1184 (0.17%)  
Mania * 1  
# participants affected / at risk     1/1184 (0.08%)  
Suicidal ideation * 1  
# participants affected / at risk     1/1184 (0.08%)  
Suicide attempt * 1  
# participants affected / at risk     1/1184 (0.08%)  
Psychotic disorder * 1  
# participants affected / at risk     1/1184 (0.08%)  
Renal and urinary disorders    
Calculus urinary * 1  
# participants affected / at risk     1/1184 (0.08%)  
Nephrotic syndrome * 1  
# participants affected / at risk     1/1184 (0.08%)  
Renal disorder * 1  
# participants affected / at risk     2/1184 (0.17%)  
Renal failure acute * 1  
# participants affected / at risk     1/1184 (0.08%)  
Renal failure chronic * 1  
# participants affected / at risk     1/1184 (0.08%)  
Urinary bladder haemorrhage * 1  
# participants affected / at risk     1/1184 (0.08%)  
Renal impairment * 1  
# participants affected / at risk     3/1184 (0.25%)  
Reproductive system and breast disorders    
Epididymitis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Respiratory, thoracic and mediastinal disorders    
Acute respiratory failure * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hypoxia * 1  
# participants affected / at risk     1/1184 (0.08%)  
Interstitial lung disease * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pneumonia aspiration * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pneumothorax * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pulmonary embolism * 1  
# participants affected / at risk     1/1184 (0.08%)  
Pulmonary oedema * 1  
# participants affected / at risk     1/1184 (0.08%)  
Respiratory arrest * 1  
# participants affected / at risk     1/1184 (0.08%)  
Skin and subcutaneous tissue disorders    
Drug eruption * 1  
# participants affected / at risk     2/1184 (0.17%)  
Erythema nodosum * 1  
# participants affected / at risk     1/1184 (0.08%)  
Rash * 1  
# participants affected / at risk     3/1184 (0.25%)  
Vascular disorders    
Circulatory collapse * 1  
# participants affected / at risk     1/1184 (0.08%)  
Hypertension * 1  
# participants affected / at risk     1/1184 (0.08%)  
Kawasaki's disease * 1  
# participants affected / at risk     1/1184 (0.08%)  
Deep vein thrombosis * 1  
# participants affected / at risk     1/1184 (0.08%)  
Intra-abdominal haematoma * 1  
# participants affected / at risk     1/1184 (0.08%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (13.1)




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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