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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Lopinavir/Ritonavir Group
Arm/Group Description	All patients in this non-interventi...
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

Baseline Characteristics

Arm/Group Title		Lopinavir/Ritonavir Group
Arm/Group Description		All patients in this non-interventi...
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
Baseline Analysis Population Description		[Not Specified]
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
Japan		1184

Outcome Measures

1.Primary Outcome


Title	Total Number of Patients With Adverse Drug Reactions
Description	Number of patients with adverse drug reactions, defined as adverse eve...
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

Outcome Measure Data

Analysis Population Description

Available data for all patients were included.


Arm/Group Title	Lopinavir/Ritonavir Group
Arm/Group Description:	All patients in this non-interventi...
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)
Description	The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts aft...
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

Outcome Measure Data

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
Arm/Group Description:	The subgroup of patients who had no...	The subgroup of patients who have r...
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
Description	Number of HIV RNA copies per mL is presented by the mean per visit for...
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

Outcome Measure Data

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
Arm/Group Description:	The subgroup of patients who had no...	The subgroup of patients who have r...
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
Description	Number of patients in each CDC category at Baseline (last assessment w...
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

Outcome Measure Data

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
Arm/Group Description:	The subgroup of patients who were c...	The subgroup of participants who we...	The subgroup of patients who were c...	The subgroup of participants who we...	The subgroup of participants who we...	The subgroup of participants who we...	The subgroup of participants whose ...
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

Adverse Events

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
Arm/Group Description	All patients in this non-interventi...
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	--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

More Information

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:	800-633-9110

Layout table for additonal information

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01076972
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

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