Non-interventional Observational Study With Viramune (Nev... | NCT00979420

Status Module

Description Module

Label	Type	Description	Intervention Names
HIV treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in log10 Viral Load From Baseline to Last Visit	Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.	Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit		Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit	Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.	Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit	Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.	Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade	Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site 1		Aachen			Germany
Boehringer Ingelheim Investigational Site 10

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
FG001	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
BG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
BG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
BG003	Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in log10 Viral Load From Baseline to Last Visit

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.

Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.

Posted

Median

Full Range

log10 copies/ml

Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune

Units	Counts
Participants	OG00086 OG00157 OG00260

Title

Denominators

Categories

Title	Measurements
	OG000-3.260± -5.61;2.25(-5.61 to 2.25) OG001-0.099± -1.69;0.70(-1.69 to 0.70) OG002-2.082± -5.82;0.40(-5.82 to 0.40)

Primary

Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit

FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Posted

Number

Participants

Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune

Units	Counts
Participants

Primary

Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.

FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Posted

Median

Full Range

CD4+ cells/mm3

Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune

Primary

Change in log10 Viral Load From Baseline to Last Visit

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.

Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Posted

Median

Full Range

log10 copies/ml

Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune

Primary

Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit

PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Posted

Number

Participants

Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune

Units	Counts
Participants

Primary

Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.

PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Posted

Median

Full Range

CD4+ cells/mm3

Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune

Secondary

Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade

Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003

Secondary

Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade

Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented

Secondary

Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented

Secondary

Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented

Secondary

Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented

Secondary

Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented

Secondary

Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented

Secondary

Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade

Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.

Posted

Number

Participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented

Secondary

Duration of Intake of Viramune

Duration of intake of Viramune

Treated set

Posted

Median

Full Range

months

End of treatment, up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune

Secondary

History of Therapy With Antiretroviral Medication

Participants with a history of therapy with antiretroviral medication.

Treated set

Posted

Number

participants

Baseline

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune

Secondary

Course of Absolute CD4+ Cell Count

The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.

PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years

Posted

Median

Full Range

CD4+ cells/mm3

Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune

Units	Counts

Secondary

Number of Participants With Drug Related Adverse Events

Number of participants with drug related Adverse Events (AEs)

Treated set

Posted

Number

participants

Up to 185 months

ID	Title	Description
OG000	Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
OG001	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG002	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
OG003	Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Bradycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected356 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0008 affected356 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Subileus	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Appendicitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected356 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Syphilis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Hemiparesis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Systematic Assessment	EG0002 affected356 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Systematic Assessment	EG0005 affected356 at risk
Premature baby	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Substance abuse	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Suicide attempt	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected356 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected356 at risk
Caesarean section	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0007 affected356 at risk
Venous thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected356 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00021 affected356 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00020 affected356 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG00025 affected356 at risk