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Trial record 4 of 244 for:    "Viral Infectious Disease" | "Lopinavir"

Drug Use Investigation of Kaletra

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ClinicalTrials.gov Identifier: NCT01076972
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : March 1, 2012
Last Update Posted : March 1, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus
Intervention Drug: Lopinavir/ritonavir (Kaletra)
Enrollment 1184
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1184
Completed 1184
Not Completed 0
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1184
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1184 participants
39.7  (11.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1184 participants
<=14 years 4
Between 15 and 64 years 1155
>=65 years 25
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1184 participants
Female
106
   9.0%
Male
1078
  91.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 1184 participants
1184
1.Primary Outcome
Title Total Number of Patients With Adverse Drug Reactions
Hide Description Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.
Time Frame During the course of the survey period up to Year 8
Hide Outcome Measure Data
Hide Analysis Population Description
Available data for all patients were included.
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1184
Measure Type: Number
Unit of Measure: participants
Any adverse drug reaction 649
Hypertriglyceridaemia 67
Hyperlipidaemia 211
Diarrhoea 130
Nausea 72
Blood triglycerides increased 99
2.Primary Outcome
Title Cluster of Differentiation 4 Lymphocyte Count (CD4)
Hide Description The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study 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
Hide Outcome Measure Data
Hide Analysis Population Description
Available data at each visit for each subgroup of patients who had not received and received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline or treatment data were missing for a given visit were excluded from the analysis for that visit.
Arm/Group Title Lopinavir/Ritonavir: Treatment-Naive Lopinavir/Ritonavir: Treatment-Experienced
Hide Arm/Group Description:
The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
Overall Number of Participants Analyzed 416 420
Mean (Standard Deviation)
Unit of Measure: cells per cubic millimeter
Baseline (Month 0 [n = 416, 420]) 125.0  (123.5) 290.6  (224.6)
Month 3 (n = 315, 283) 257.2  (170.8) 342.9  (230.5)
Month 6 (n = 288, 252) 275.9  (175.4) 366.4  (227.0)
Month 9 (n = 223, 238) 311.1  (175.1) 385.0  (224.3)
Month 12 (Year 1 [n = 201, 233]) 329.9  (178.6) 410.4  (214.7)
Year 2 (n = 146, 190) 419.4  (201.1) 437.4  (224.2)
Year 3 (n = 106, 150) 455.6  (202.4) 481.5  (255.4)
Year 4 (n = 69, 99) 475.2  (209.6) 526.6  (296.4)
Year 5 (n = 40, 73) 535.1  (248.0) 496.2  (228.7)
Year 6 (n = 25, 42) 577.1  (241.9) 569.7  (287.0)
Year 7 (n = 3, 17) 602.0  (156.1) 597.7  (224.2)
Year 8 (n = 0, 3) NA [1]   (NA) 493.7  (414.8)
[1]
No data were recorded for any patients at this visit.
3.Primary Outcome
Title Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit
Hide Description Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study 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
Hide Outcome Measure Data
Hide Analysis Population Description
Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.
Arm/Group Title Lopinavir/Ritonavir: Treatment-Naive Lopinavir/Ritonavir: Treatment-experienced
Hide Arm/Group Description:
The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
Overall Number of Participants Analyzed 416 418
Mean (Standard Deviation)
Unit of Measure: copies/mL
Baseline (Month 0 [n = 416, 418]) 4.9  (0.8) 3.5  (1.1)
Month 3 (n = 315, 280) 2.7  (0.4) 2.8  (0.5)
Month 6 (n = 288, 253) 2.7  (0.3) 2.8  (0.6)
Month 9 (n = 224, 238) 2.6  (0.3) 2.8  (0.5)
Month 12 (Year 1 [n = 203, 230]) 2.7  (0.4) 2.8  (0.6)
Year 2 (n = 145, 190) 2.7  (0.3) 2.7  (0.5)
Year 3 (n = 107, 147) 2.6  (0.1) 2.7  (0.4)
Year 4 (n = 70, 99) 2.6  (0.1) 2.7  (0.4)
Year 5 (n = 39, 72) 2.7  (0.3) 2.8  (0.5)
Year 6 (n = 25, 41) 2.7  (0.3) 2.6  (0.3)
Year 7 (n = 3, 17) 2.6  (0.0) 2.8  (0.6)
Year 8 (n = 0, 3) NA [1]   (NA) 2.6  (0.0)
[1]
No data were recorded for any patients at this visit.
4.Primary Outcome
Title Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents
Hide Description Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).
Time Frame Baseline (Month 0) and following last treatment dose during the course of the survey period
Hide Outcome Measure Data
Hide Analysis Population Description
Available data for all patients were included.
Arm/Group Title Lopinavir/Ritonavir: Baseline Category A Lopinavir/Ritonavir: Baseline Category B Lopinavir/Ritonavir: Baseline Category C Lopinavir/Ritonavir: Baseline Category P-0 Lopinavir/Ritonavir: Baseline Category P-1 Lopinavir/Ritonavir: Baseline Category P-2 Lopinavir/Ritonavir: Baseline Category Unknown
Hide Arm/Group Description:
The subgroup of patients who were classified as CDC Category A at Baseline (prior to treatment with lopinavir/ritonavir).
The subgroup of participants who were classified as CDC Category B at Baseline (prior to treatment with lopinavir/ritonavir).
The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).
The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).
The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).
The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).
The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
Overall Number of Participants Analyzed 378 71 323 0 0 1 411
Measure Type: Number
Unit of Measure: participants
Category A after lopinavir/ritonavir treatment 206 0 0 0 103
Category B after lopinavir/ritonavir treatment 2 32 0 0 22
Category C after lopinavir/ritonavir treatment 6 2 191 0 86
Category P-0 after lopinavir/ritonavir treatment 0 0 0 0 0
Category P-1 after lopinavir/ritonavir treatment 0 0 0 0 1
Category P-2 after lopinavir/ritonavir treatment 0 0 0 0 0
Category unknown after treatment 164 37 132 1 199
Time Frame During the course of the survey period up to Year 8.
Adverse Event Reporting 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.
 
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description 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.
All-Cause Mortality
Lopinavir/Ritonavir Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lopinavir/Ritonavir Group
Affected / at Risk (%)
Total   189/1184 (15.96%) 
Blood and lymphatic system disorders   
Anaemia * 1  13/1184 (1.10%) 
Disseminated intravascular coagulation * 1  2/1184 (0.17%) 
Febrile neutropenia * 1  1/1184 (0.08%) 
Iron deficiency anaemia * 1  1/1184 (0.08%) 
Leukopenia * 1  1/1184 (0.08%) 
Lymphadenitis * 1  1/1184 (0.08%) 
Neutropenia * 1  1/1184 (0.08%) 
Pancytopenia * 1  5/1184 (0.42%) 
Thrombocytopenia * 1  1/1184 (0.08%) 
Thrombocytopenic purpura * 1  1/1184 (0.08%) 
Bone marrow failure * 1  1/1184 (0.08%) 
Cardiac disorders   
Acute myocardial infarction * 1  1/1184 (0.08%) 
Arrhythmia * 1  1/1184 (0.08%) 
Atrioventricular block * 1  1/1184 (0.08%) 
Atrioventricular block complete * 1  1/1184 (0.08%) 
Bradycardia * 1  1/1184 (0.08%) 
Cardiac failure * 1  2/1184 (0.17%) 
Cardiac failure congestive * 1  1/1184 (0.08%) 
Conduction disorder * 1  1/1184 (0.08%) 
Left ventricular failure * 1  1/1184 (0.08%) 
Myocardial infarction * 1  2/1184 (0.17%) 
Myocarditis * 1  1/1184 (0.08%) 
Palpitations * 1  2/1184 (0.17%) 
Sinus arrest * 1  1/1184 (0.08%) 
Sinus bradycardia * 1  1/1184 (0.08%) 
Tachycardia * 1  2/1184 (0.17%) 
Congenital, familial and genetic disorders   
Fanconi syndrome * 1  1/1184 (0.08%) 
Endocrine disorders   
Adrenal insufficiency * 1  1/1184 (0.08%) 
Hyperthyroidism * 1  1/1184 (0.08%) 
Eye disorders   
Cataract * 1  1/1184 (0.08%) 
Retinal detachment * 1  1/1184 (0.08%) 
Ulcerative keratitis * 1  1/1184 (0.08%) 
Gastrointestinal disorders   
Acute abdomen * 1  1/1184 (0.08%) 
Anorectal disorder * 1  1/1184 (0.08%) 
Ascites * 1  3/1184 (0.25%) 
Colitis * 1  1/1184 (0.08%) 
Diarrhoea * 1  3/1184 (0.25%) 
Duodenal ulcer * 1  1/1184 (0.08%) 
Duodenal ulcer haemorrhage * 1  1/1184 (0.08%) 
Enterocolitis * 1  1/1184 (0.08%) 
Enterocolitis haemorrhagic * 1  1/1184 (0.08%) 
Gastric ulcer * 1  1/1184 (0.08%) 
Ileus * 1  3/1184 (0.25%) 
Intestinal obstruction * 1  2/1184 (0.17%) 
Nausea * 1  3/1184 (0.25%) 
Pancreatitis acute * 1  3/1184 (0.25%) 
Pancreatitis relapsing * 1  1/1184 (0.08%) 
Vomiting * 1  3/1184 (0.25%) 
Subileus * 1  1/1184 (0.08%) 
General disorders   
Death * 1  2/1184 (0.17%) 
Necrosis * 1  1/1184 (0.08%) 
Pyrexia * 1  1/1184 (0.08%) 
Hepatobiliary disorders   
Cholecystitis acute * 1  3/1184 (0.25%) 
Cholelithiasis * 1  1/1184 (0.08%) 
Hepatic cirrhosis * 1  2/1184 (0.17%) 
Hepatic failure * 1  3/1184 (0.25%) 
Hepatic function abnormal * 1  3/1184 (0.25%) 
Hepatitis acute * 1  1/1184 (0.08%) 
Hepatitis fulminant * 1  1/1184 (0.08%) 
Jaundice * 1  2/1184 (0.17%) 
Liver disorder * 1  3/1184 (0.25%) 
Immune system disorders   
Behcet's syndrome * 1  1/1184 (0.08%) 
Hypersensitivity * 1  1/1184 (0.08%) 
Immune reconstitution syndrome * 1  8/1184 (0.68%) 
Infections and infestations   
Acute tonsillitis * 1  1/1184 (0.08%) 
Amoebic dysentery * 1  1/1184 (0.08%) 
Appendicitis * 1  3/1184 (0.25%) 
Bronchitis * 1  2/1184 (0.17%) 
Cellulitis * 1  2/1184 (0.17%) 
Cryptosporidiosis infection * 1  1/1184 (0.08%) 
Cytomegalovirus infection * 1  1/1184 (0.08%) 
Disseminated tuberculosis * 1  1/1184 (0.08%) 
Gastroenteritis * 1  1/1184 (0.08%) 
Gastroenteritis salmonella * 1  1/1184 (0.08%) 
Genital herpes * 1  1/1184 (0.08%) 
Giardiasis * 1  1/1184 (0.08%) 
Hepatitis B * 1  1/1184 (0.08%) 
Herpes zoster * 1  10/1184 (0.84%) 
Influenza * 1  1/1184 (0.08%) 
Measles * 1  1/1184 (0.08%) 
Meningitis cryptococcal * 1  2/1184 (0.17%) 
Meningitis herpes * 1  1/1184 (0.08%) 
Neurosyphilis * 1  1/1184 (0.08%) 
Oesophageal candidiasis * 1  1/1184 (0.08%) 
Oral candidiasis * 1  1/1184 (0.08%) 
Otitis media * 1  1/1184 (0.08%) 
Pharyngitis * 1  1/1184 (0.08%) 
Pneumonia * 1  7/1184 (0.59%) 
Pneumonia pneumococcal * 1  1/1184 (0.08%) 
Progressive multifocal leukoencephalopathy * 1  1/1184 (0.08%) 
Prostatic abscess * 1  1/1184 (0.08%) 
Pyelonephritis * 1  1/1184 (0.08%) 
Septic shock * 1  2/1184 (0.17%) 
Tonsillitis * 1  2/1184 (0.17%) 
Cytomegalovirus chorioretinitis * 1  4/1184 (0.34%) 
AIDS encephalopathy * 1  2/1184 (0.17%) 
Staphylococcal sepsis * 1  2/1184 (0.17%) 
Cerebral toxoplasmosis * 1  2/1184 (0.17%) 
Staphylococcal infection * 1  1/1184 (0.08%) 
Mycobacterium avium complex infection * 1  1/1184 (0.08%) 
Anogenital warts * 1  2/1184 (0.17%) 
Tuberculosis gastrointestinal * 1  1/1184 (0.08%) 
Atypical mycobacterial infection * 1  2/1184 (0.17%) 
Hepatic amoebiasis * 1  1/1184 (0.08%) 
Pneumocystis jiroveci pneumonia * 1  5/1184 (0.42%) 
Extrapulmonary tuberculosis * 1  1/1184 (0.08%) 
Enterocolitis bacterial * 1  1/1184 (0.08%) 
Oral herpes * 1  1/1184 (0.08%) 
Injury, poisoning and procedural complications   
Femoral neck fracture * 1  1/1184 (0.08%) 
Fracture * 1  1/1184 (0.08%) 
Intentional overdose * 1  1/1184 (0.08%) 
Spinal compression fracture * 1  1/1184 (0.08%) 
Subdural haematoma * 1  3/1184 (0.25%) 
Investigations   
C-reactive protein increased * 1  1/1184 (0.08%) 
Chest X-ray abnormal * 1  1/1184 (0.08%) 
Platelet count decreased * 1  6/1184 (0.51%) 
Red blood cell count decreased * 1  1/1184 (0.08%) 
White blood cell count decreased * 1  4/1184 (0.34%) 
Protein urine present * 1  1/1184 (0.08%) 
Transaminases increased * 1  1/1184 (0.08%) 
Metabolism and nutrition disorders   
Cachexia * 1  1/1184 (0.08%) 
Dehydration * 1  1/1184 (0.08%) 
Diabetes mellitus * 1  3/1184 (0.25%) 
Glucose tolerance impaired * 1  1/1184 (0.08%) 
Hyperkalaemia * 1  1/1184 (0.08%) 
Hyperlactacidaemia * 1  4/1184 (0.34%) 
Hypoalbuminaemia * 1  1/1184 (0.08%) 
Hypokalaemia * 1  2/1184 (0.17%) 
Lactic acidosis * 1  3/1184 (0.25%) 
Malnutrition * 1  1/1184 (0.08%) 
Decreased appetite * 1  1/1184 (0.08%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/1184 (0.08%) 
Osteomalacia * 1  1/1184 (0.08%) 
Osteonecrosis * 1  1/1184 (0.08%) 
Pain in extremity * 1  1/1184 (0.08%) 
Rhabdomyolysis * 1  1/1184 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia * 1  1/1184 (0.08%) 
Breast cancer recurrent * 1  1/1184 (0.08%) 
Central nervous system lymphoma * 1  1/1184 (0.08%) 
Gastric cancer * 1  1/1184 (0.08%) 
Glioma * 1  1/1184 (0.08%) 
Hepatic neoplasm malignant * 1  3/1184 (0.25%) 
Kaposi's sarcoma * 1  1/1184 (0.08%) 
Lymphoma * 1  2/1184 (0.17%) 
Malignant pleural effusion * 1  1/1184 (0.08%) 
Metastases to lung * 1  1/1184 (0.08%) 
Metastases to pleura * 1  1/1184 (0.08%) 
Rectal cancer * 1  1/1184 (0.08%) 
Squamous cell carcinoma * 1  1/1184 (0.08%) 
Lung neoplasm malignant * 1  1/1184 (0.08%) 
Large intestine carcinoma * 1  1/1184 (0.08%) 
Anal cancer * 1  1/1184 (0.08%) 
Nervous system disorders   
Cerebral haemorrhage * 1  4/1184 (0.34%) 
Cerebral infarction * 1  4/1184 (0.34%) 
Convulsion * 1  5/1184 (0.42%) 
Encephalitis * 1  2/1184 (0.17%) 
Epilepsy * 1  3/1184 (0.25%) 
Guillain-Barre syndrome * 1  1/1184 (0.08%) 
Hemiparesis * 1  1/1184 (0.08%) 
Hemiplegia * 1  1/1184 (0.08%) 
Hepatic encephalopathy * 1  2/1184 (0.17%) 
Hypoaesthesia * 1  1/1184 (0.08%) 
Loss of consciousness * 1  3/1184 (0.25%) 
Memory impairment * 1  1/1184 (0.08%) 
Myelitis * 1  1/1184 (0.08%) 
Neuropathy peripheral * 1  1/1184 (0.08%) 
Paralysis * 1  1/1184 (0.08%) 
Status epilepticus * 1  1/1184 (0.08%) 
Subarachnoid haemorrhage * 1  1/1184 (0.08%) 
Tremor * 1  1/1184 (0.08%) 
VIIth nerve paralysis * 1  1/1184 (0.08%) 
Psychiatric disorders   
Anxiety * 1  1/1184 (0.08%) 
Depression * 1  2/1184 (0.17%) 
Eating disorder * 1  1/1184 (0.08%) 
Emotional disorder * 1  1/1184 (0.08%) 
Hallucination, auditory * 1  1/1184 (0.08%) 
Insomnia * 1  2/1184 (0.17%) 
Mania * 1  1/1184 (0.08%) 
Suicidal ideation * 1  1/1184 (0.08%) 
Suicide attempt * 1  1/1184 (0.08%) 
Psychotic disorder * 1  1/1184 (0.08%) 
Renal and urinary disorders   
Calculus urinary * 1  1/1184 (0.08%) 
Nephrotic syndrome * 1  1/1184 (0.08%) 
Renal disorder * 1  2/1184 (0.17%) 
Renal failure acute * 1  1/1184 (0.08%) 
Renal failure chronic * 1  1/1184 (0.08%) 
Urinary bladder haemorrhage * 1  1/1184 (0.08%) 
Renal impairment * 1  3/1184 (0.25%) 
Reproductive system and breast disorders   
Epididymitis * 1  1/1184 (0.08%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/1184 (0.08%) 
Hypoxia * 1  1/1184 (0.08%) 
Interstitial lung disease * 1  1/1184 (0.08%) 
Pneumonia aspiration * 1  1/1184 (0.08%) 
Pneumothorax * 1  1/1184 (0.08%) 
Pulmonary embolism * 1  1/1184 (0.08%) 
Pulmonary oedema * 1  1/1184 (0.08%) 
Respiratory arrest * 1  1/1184 (0.08%) 
Skin and subcutaneous tissue disorders   
Drug eruption * 1  2/1184 (0.17%) 
Erythema nodosum * 1  1/1184 (0.08%) 
Rash * 1  3/1184 (0.25%) 
Vascular disorders   
Circulatory collapse * 1  1/1184 (0.08%) 
Hypertension * 1  1/1184 (0.08%) 
Kawasaki's disease * 1  1/1184 (0.08%) 
Deep vein thrombosis * 1  1/1184 (0.08%) 
Intra-abdominal haematoma * 1  1/1184 (0.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lopinavir/Ritonavir Group
Affected / at Risk (%)
Total   539/1184 (45.52%) 
Gastrointestinal disorders   
Diarrhoea * 1  148/1184 (12.50%) 
Nausea * 1  87/1184 (7.35%) 
Investigations   
Blood triglycerides increased * 1  104/1184 (8.78%) 
Metabolism and nutrition disorders   
Hypertriglyceridaemia * 1  77/1184 (6.50%) 
Hyperlipidaemia * 1  230/1184 (19.43%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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
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Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01076972     History of Changes
Other Study ID Numbers: PMOS-JAP-00-001
First Submitted: February 25, 2010
First Posted: February 26, 2010
Results First Submitted: December 9, 2011
Results First Posted: March 1, 2012
Last Update Posted: March 1, 2012