Drug Use Investigation of Kaletra

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01076972
• Collaborator: (none)
• Enrollment: 1,184
• Locations: 29
• Duration (Months): 120
• Patients Per Site: 40.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This non-interventional, post-marketing observational study was conducted to obtain data, such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical practice and investigate the necessity to conduct a follow-up post-marketing clinical study in Japan.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Drug: Lopinavir/ritonavir (Kaletra)

Study Design

• Study Type: Observational
• Actual Enrollment: 1184 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Drug Use Investigation of Kaletra
• Study Start Date: Dec 1, 2000
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Lopinavir/ritonavir (Kaletra); Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.; Other Names: Lopinavir/ritonavir Kaletra

Outcome Measures

Primary Outcome Measures

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

   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.

2. Cluster of Differentiation 4 Lymphocyte Count (CD4) [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]

   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.

3. Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit [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]

   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.

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

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients prescribed Kaletra for the treatment of HIV are eligible for this survey.

Exclusion Criteria:

• Contraindications according to the Package Insert:

• Patients with a history of hypersensitivity to any ingredient of Kaletra

• Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 36516	Aichi		Japan
2	Site Reference ID/Investigator# 36517	Aichi		Japan
3	Site Reference ID/Investigator# 36518	Chiba		Japan
4	Site Reference ID/Investigator# 36519	Fukuoka		Japan
5	Site Reference ID/Investigator# 36521	Fukuoka		Japan
6	Site Reference ID/Investigator# 36522	Hiroshima		Japan
7	Site Reference ID/Investigator# 36523	Hokkaido		Japan
8	Site Reference ID/Investigator# 36524	Hyogo		Japan
9	Site Reference ID/Investigator# 36525	Kanagawa		Japan
10	Site Reference ID/Investigator# 36526	Kyoto		Japan
11	Site Reference ID/Investigator# 36622	Miyagi		Japan
12	Site Reference ID/Investigator# 36623	Miyagi		Japan
13	Site Reference ID/Investigator# 36624	Niigata		Japan
14	Site Reference ID/Investigator# 36625	Okayama		Japan
15	Site Reference ID/Investigator# 36626	Osaka		Japan
16	Site Reference ID/Investigator# 36627	Osaka		Japan
17	Site Reference ID/Investigator# 36628	Shizuoka		Japan
18	Site Reference ID/Investigator# 36629	Tokyo		Japan
19	Site Reference ID/Investigator# 36630	Tokyo		Japan
20	Site Reference ID/Investigator# 36631	Tokyo		Japan
21	Site Reference ID/Investigator# 36632	Tokyo		Japan
22	Site Reference ID/Investigator# 36633	Tokyo		Japan
23	Site Reference ID/Investigator# 36634	Tokyo		Japan
24	Site Reference ID/Investigator# 36635	Tokyo		Japan
25	Site Reference ID/Investigator# 36636	Tokyo		Japan
26	Site Reference ID/Investigator# 36637	Tokyo		Japan
27	Site Reference ID/Investigator# 36638	Tokyo		Japan
28	Site Reference ID/Investigator# 36639	Tokyo		Japan
29	Site Reference ID/Investigator# 5342	Tokyo		Japan

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Yo Hoshino, Abbott Japan Co.,Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01076972
• Other Study ID Numbers: PMOS-JAP-00-001
• First Posted: Feb 26, 2010
• Last Update Posted: Mar 1, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Abbott: Human Immunodeficiency Virus
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Ritonavir; Lopinavir

Study Results

Participant Flow

Arm/Group Title	Lopinavir/Ritonavir Group
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-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 Participants	1184
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.7 (11.0)
Age, Customized (participants) [Number]
<=14 years	4 0.3%
Between 15 and 64 years	1155 97.6%
>=65 years	25 2.1%
Sex: Female, Male (Count of Participants)
Female	106 9%
Male	1078 91%
Region of Enrollment (participants) [Number]
Japan	1184 100%

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 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-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
Measure Participants	1184
Any adverse drug reaction	649 54.8%
Hypertriglyceridaemia	67 5.7%
Hyperlipidaemia	211 17.8%
Diarrhoea	130 11%
Nausea	72 6.1%
Blood triglycerides increased	99 8.4%

2. Primary Outcome

Title	Cluster of Differentiation 4 Lymphocyte Count (CD4)
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 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.
Measure Participants	416	420
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 (NA)	493.7 (414.8)

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 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 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.
Measure Participants	416	418
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 (NA)	2.6 (0.0)

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 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 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.
Measure Participants	378	71	323	0	0	1	411
Category A after lopinavir/ritonavir treatment	206 17.4%	0 NaN	0 NaN	0 NaN	103 NaN
Category B after lopinavir/ritonavir treatment	2 0.2%	32 NaN	0 NaN	0 NaN	22 NaN
Category C after lopinavir/ritonavir treatment	6 0.5%	2 NaN	191 NaN	0 NaN	86 NaN
Category P-0 after lopinavir/ritonavir treatment	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Category P-1 after lopinavir/ritonavir treatment	0 0%	0 NaN	0 NaN	0 NaN	1 NaN
Category P-2 after lopinavir/ritonavir treatment	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Category unknown after treatment	164 13.9%	37 NaN	132 NaN	1 NaN	199 NaN

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-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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lopinavir/Ritonavir Group
	Affected / at Risk (%)	# Events
Total	189/1184 (16%)
Blood and lymphatic system disorders
Anaemia	13/1184 (1.1%)
Disseminated intravascular coagulation	2/1184 (0.2%)
Febrile neutropenia	1/1184 (0.1%)
Iron deficiency anaemia	1/1184 (0.1%)
Leukopenia	1/1184 (0.1%)
Lymphadenitis	1/1184 (0.1%)
Neutropenia	1/1184 (0.1%)
Pancytopenia	5/1184 (0.4%)
Thrombocytopenia	1/1184 (0.1%)
Thrombocytopenic purpura	1/1184 (0.1%)
Bone marrow failure	1/1184 (0.1%)
Cardiac disorders
Acute myocardial infarction	1/1184 (0.1%)
Arrhythmia	1/1184 (0.1%)
Atrioventricular block	1/1184 (0.1%)
Atrioventricular block complete	1/1184 (0.1%)
Bradycardia	1/1184 (0.1%)
Cardiac failure	2/1184 (0.2%)
Cardiac failure congestive	1/1184 (0.1%)
Conduction disorder	1/1184 (0.1%)
Left ventricular failure	1/1184 (0.1%)
Myocardial infarction	2/1184 (0.2%)
Myocarditis	1/1184 (0.1%)
Palpitations	2/1184 (0.2%)
Sinus arrest	1/1184 (0.1%)
Sinus bradycardia	1/1184 (0.1%)
Tachycardia	2/1184 (0.2%)
Congenital, familial and genetic disorders
Fanconi syndrome	1/1184 (0.1%)
Endocrine disorders
Adrenal insufficiency	1/1184 (0.1%)
Hyperthyroidism	1/1184 (0.1%)
Eye disorders
Cataract	1/1184 (0.1%)
Retinal detachment	1/1184 (0.1%)
Ulcerative keratitis	1/1184 (0.1%)
Gastrointestinal disorders
Acute abdomen	1/1184 (0.1%)
Anorectal disorder	1/1184 (0.1%)
Ascites	3/1184 (0.3%)
Colitis	1/1184 (0.1%)
Diarrhoea	3/1184 (0.3%)
Duodenal ulcer	1/1184 (0.1%)
Duodenal ulcer haemorrhage	1/1184 (0.1%)
Enterocolitis	1/1184 (0.1%)
Enterocolitis haemorrhagic	1/1184 (0.1%)
Gastric ulcer	1/1184 (0.1%)
Ileus	3/1184 (0.3%)
Intestinal obstruction	2/1184 (0.2%)
Nausea	3/1184 (0.3%)
Pancreatitis acute	3/1184 (0.3%)
Pancreatitis relapsing	1/1184 (0.1%)
Vomiting	3/1184 (0.3%)
Subileus	1/1184 (0.1%)
General disorders
Death	2/1184 (0.2%)
Necrosis	1/1184 (0.1%)
Pyrexia	1/1184 (0.1%)
Hepatobiliary disorders
Cholecystitis acute	3/1184 (0.3%)
Cholelithiasis	1/1184 (0.1%)
Hepatic cirrhosis	2/1184 (0.2%)
Hepatic failure	3/1184 (0.3%)
Hepatic function abnormal	3/1184 (0.3%)
Hepatitis acute	1/1184 (0.1%)
Hepatitis fulminant	1/1184 (0.1%)
Jaundice	2/1184 (0.2%)
Liver disorder	3/1184 (0.3%)
Immune system disorders
Behcet's syndrome	1/1184 (0.1%)
Hypersensitivity	1/1184 (0.1%)
Immune reconstitution syndrome	8/1184 (0.7%)
Infections and infestations
Acute tonsillitis	1/1184 (0.1%)
Amoebic dysentery	1/1184 (0.1%)
Appendicitis	3/1184 (0.3%)
Bronchitis	2/1184 (0.2%)
Cellulitis	2/1184 (0.2%)
Cryptosporidiosis infection	1/1184 (0.1%)
Cytomegalovirus infection	1/1184 (0.1%)
Disseminated tuberculosis	1/1184 (0.1%)
Gastroenteritis	1/1184 (0.1%)
Gastroenteritis salmonella	1/1184 (0.1%)
Genital herpes	1/1184 (0.1%)
Giardiasis	1/1184 (0.1%)
Hepatitis B	1/1184 (0.1%)
Herpes zoster	10/1184 (0.8%)
Influenza	1/1184 (0.1%)
Measles	1/1184 (0.1%)
Meningitis cryptococcal	2/1184 (0.2%)
Meningitis herpes	1/1184 (0.1%)
Neurosyphilis	1/1184 (0.1%)
Oesophageal candidiasis	1/1184 (0.1%)
Oral candidiasis	1/1184 (0.1%)
Otitis media	1/1184 (0.1%)
Pharyngitis	1/1184 (0.1%)
Pneumonia	7/1184 (0.6%)
Pneumonia pneumococcal	1/1184 (0.1%)
Progressive multifocal leukoencephalopathy	1/1184 (0.1%)
Prostatic abscess	1/1184 (0.1%)
Pyelonephritis	1/1184 (0.1%)
Septic shock	2/1184 (0.2%)
Tonsillitis	2/1184 (0.2%)
Cytomegalovirus chorioretinitis	4/1184 (0.3%)
AIDS encephalopathy	2/1184 (0.2%)
Staphylococcal sepsis	2/1184 (0.2%)
Cerebral toxoplasmosis	2/1184 (0.2%)
Staphylococcal infection	1/1184 (0.1%)
Mycobacterium avium complex infection	1/1184 (0.1%)
Anogenital warts	2/1184 (0.2%)
Tuberculosis gastrointestinal	1/1184 (0.1%)
Atypical mycobacterial infection	2/1184 (0.2%)
Hepatic amoebiasis	1/1184 (0.1%)
Pneumocystis jiroveci pneumonia	5/1184 (0.4%)
Extrapulmonary tuberculosis	1/1184 (0.1%)
Enterocolitis bacterial	1/1184 (0.1%)
Oral herpes	1/1184 (0.1%)
Injury, poisoning and procedural complications
Femoral neck fracture	1/1184 (0.1%)
Fracture	1/1184 (0.1%)
Intentional overdose	1/1184 (0.1%)
Spinal compression fracture	1/1184 (0.1%)
Subdural haematoma	3/1184 (0.3%)
Investigations
C-reactive protein increased	1/1184 (0.1%)
Chest X-ray abnormal	1/1184 (0.1%)
Platelet count decreased	6/1184 (0.5%)
Red blood cell count decreased	1/1184 (0.1%)
White blood cell count decreased	4/1184 (0.3%)
Protein urine present	1/1184 (0.1%)
Transaminases increased	1/1184 (0.1%)
Metabolism and nutrition disorders
Cachexia	1/1184 (0.1%)
Dehydration	1/1184 (0.1%)
Diabetes mellitus	3/1184 (0.3%)
Glucose tolerance impaired	1/1184 (0.1%)
Hyperkalaemia	1/1184 (0.1%)
Hyperlactacidaemia	4/1184 (0.3%)
Hypoalbuminaemia	1/1184 (0.1%)
Hypokalaemia	2/1184 (0.2%)
Lactic acidosis	3/1184 (0.3%)
Malnutrition	1/1184 (0.1%)
Decreased appetite	1/1184 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/1184 (0.1%)
Osteomalacia	1/1184 (0.1%)
Osteonecrosis	1/1184 (0.1%)
Pain in extremity	1/1184 (0.1%)
Rhabdomyolysis	1/1184 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/1184 (0.1%)
Breast cancer recurrent	1/1184 (0.1%)
Central nervous system lymphoma	1/1184 (0.1%)
Gastric cancer	1/1184 (0.1%)
Glioma	1/1184 (0.1%)
Hepatic neoplasm malignant	3/1184 (0.3%)
Kaposi's sarcoma	1/1184 (0.1%)
Lymphoma	2/1184 (0.2%)
Malignant pleural effusion	1/1184 (0.1%)
Metastases to lung	1/1184 (0.1%)
Metastases to pleura	1/1184 (0.1%)
Rectal cancer	1/1184 (0.1%)
Squamous cell carcinoma	1/1184 (0.1%)
Lung neoplasm malignant	1/1184 (0.1%)
Large intestine carcinoma	1/1184 (0.1%)
Anal cancer	1/1184 (0.1%)
Nervous system disorders
Cerebral haemorrhage	4/1184 (0.3%)
Cerebral infarction	4/1184 (0.3%)
Convulsion	5/1184 (0.4%)
Encephalitis	2/1184 (0.2%)
Epilepsy	3/1184 (0.3%)
Guillain-Barre syndrome	1/1184 (0.1%)
Hemiparesis	1/1184 (0.1%)
Hemiplegia	1/1184 (0.1%)
Hepatic encephalopathy	2/1184 (0.2%)
Hypoaesthesia	1/1184 (0.1%)
Loss of consciousness	3/1184 (0.3%)
Memory impairment	1/1184 (0.1%)
Myelitis	1/1184 (0.1%)
Neuropathy peripheral	1/1184 (0.1%)
Paralysis	1/1184 (0.1%)
Status epilepticus	1/1184 (0.1%)
Subarachnoid haemorrhage	1/1184 (0.1%)
Tremor	1/1184 (0.1%)
VIIth nerve paralysis	1/1184 (0.1%)
Psychiatric disorders
Anxiety	1/1184 (0.1%)
Depression	2/1184 (0.2%)
Eating disorder	1/1184 (0.1%)
Emotional disorder	1/1184 (0.1%)
Hallucination, auditory	1/1184 (0.1%)
Insomnia	2/1184 (0.2%)
Mania	1/1184 (0.1%)
Suicidal ideation	1/1184 (0.1%)
Suicide attempt	1/1184 (0.1%)
Psychotic disorder	1/1184 (0.1%)
Renal and urinary disorders
Calculus urinary	1/1184 (0.1%)
Nephrotic syndrome	1/1184 (0.1%)
Renal disorder	2/1184 (0.2%)
Renal failure acute	1/1184 (0.1%)
Renal failure chronic	1/1184 (0.1%)
Urinary bladder haemorrhage	1/1184 (0.1%)
Renal impairment	3/1184 (0.3%)
Reproductive system and breast disorders
Epididymitis	1/1184 (0.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/1184 (0.1%)
Hypoxia	1/1184 (0.1%)
Interstitial lung disease	1/1184 (0.1%)
Pneumonia aspiration	1/1184 (0.1%)
Pneumothorax	1/1184 (0.1%)
Pulmonary embolism	1/1184 (0.1%)
Pulmonary oedema	1/1184 (0.1%)
Respiratory arrest	1/1184 (0.1%)
Skin and subcutaneous tissue disorders
Drug eruption	2/1184 (0.2%)
Erythema nodosum	1/1184 (0.1%)
Rash	3/1184 (0.3%)
Vascular disorders
Circulatory collapse	1/1184 (0.1%)
Hypertension	1/1184 (0.1%)
Kawasaki's disease	1/1184 (0.1%)
Deep vein thrombosis	1/1184 (0.1%)
Intra-abdominal haematoma	1/1184 (0.1%)
Other (Not Including Serious) Adverse Events
	Lopinavir/Ritonavir Group
	Affected / at Risk (%)	# Events
Total	539/1184 (45.5%)
Gastrointestinal disorders
Diarrhoea	148/1184 (12.5%)
Nausea	87/1184 (7.3%)
Investigations
Blood triglycerides increased	104/1184 (8.8%)
Metabolism and nutrition disorders
Hypertriglyceridaemia	77/1184 (6.5%)
Hyperlipidaemia	230/1184 (19.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.