Non-Interventional Observational Study With Viramune Plus... | NCT00876733

Label	Type	Description	Intervention Names
HIV treatment

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs	Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs	36 months

Measure	Description	Time Frame
Changes in the Viral Load After 12 Months From Baseline.	The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.	Baseline and 12 months
Changes in the Viral Load After 36 Months From Baseline.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site 14		Aachen			Germany
Boehringer Ingelheim Investigational Site 12

ID	Title	Description
FG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
FG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.

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

Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs

Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs

Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.

Posted

Number

participants

36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented	Patients who could not be assigned to one of the three subgroups and had no documented viral load value.

Units	Counts
Participants	OG000288 OG001203 OG00293 OG003

Title

Denominators

Categories

Patients with any AE

Title	Measurements
	OG000168 OG001110 OG00251 OG003

Secondary

Changes in the Viral Load After 12 Months From Baseline.

The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.

Patients from FAS with values for viral load at baseline and after 12 months.

Posted

Mean

Standard Deviation

Log10 copies/ml

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Viral Load After 36 Months From Baseline.

The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.

Patients from FAS with values for viral load at baseline and after 36 months.

Posted

Mean

Standard Deviation

Log10 copies/ml

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.

The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.

Patients from FAS with values for CD4+ at baseline and after 12 months.

Posted

Mean

Standard Deviation

cells/mm^3

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the CD4+ Cell Count After 36 Months From Baseline.

The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.

Patients from FAS with values for CD4+ at baseline and after 36 months.

Posted

Mean

Standard Deviation

cells/mm^3

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline

The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline

The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline

The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline

The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Triglycerides at baseline and at month 12.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline

The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (ALT) After 12 Months From Baseline

The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for ALT at baseline and at month 12.

Posted

Mean

Standard Deviation

U/L

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (AST) After 12 Months From Baseline

The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for AST at baseline and at month 12.

Posted

Mean

Standard Deviation

U/L

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline

The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Gamma GT at baseline and at month 12.

Posted

Mean

Standard Deviation

U/L

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline

The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Creatinine at baseline and at month 12.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline

The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.

Posted

Mean

Standard Deviation

g/dL

Baseline and 12 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline

The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline

The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline

The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline

The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Triglycerides at baseline and at month 36.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline

The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (ALT) After 36 Months From Baseline

The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for ALT at baseline and at month 36.

Posted

Mean

Standard Deviation

U/L

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (AST) After 36 Months From Baseline

The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for AST at baseline and at month 36.

Posted

Mean

Standard Deviation

U/L

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline

The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Gamma GT at baseline and at month 36.

Posted

Mean

Standard Deviation

U/L

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline

The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Creatinine at baseline and at month 12.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Secondary

Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline

The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.

Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.

Posted

Mean

Standard Deviation

g/dL

Baseline and 36 months

ID	Title	Description
OG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
OG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
OG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
OG003	Patients With Baseline Viral Load Not Documented

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Colitis	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG0030 affected21 at risk
Diarrhoea	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0002 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Intestinal stenosis	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Nausea	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Vomiting	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Chest pain	General disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Device occlusion	General disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Local swelling	General disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Tenderness	General disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Acute hepatitis C	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Appendicitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Bronchiolitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Bronchopneumonia	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Cellulitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Herpes zoster	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Meningoencephalitis herpetic	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Myelitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Peritonitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Sepsis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Urinary tract infection	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Biopsy	Investigations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Hepatic enzyme abnormal	Investigations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Transaminases increased	Investigations	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Dehydration	Metabolism and nutrition disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Hypopharyngeal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Cerebral infarction	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Convulsion	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Acute stress disorder	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Alcoholism	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Anxiety disorder	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Depression	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0010 affected203 at risk EG0022 affected93 at risk EG003
Psychotic disorder	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Somatoform disorder	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Acute prerenal failure	Renal and urinary disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Epididymitis	Reproductive system and breast disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Bursa removal	Surgical and medical procedures	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0010 affected203 at risk EG0021 affected93 at risk EG003
Laparoscopic surgery	Surgical and medical procedures	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003
Laser therapy	Surgical and medical procedures	MEDDRA 17.0	Systematic Assessment	EG0001 affected288 at risk EG0010 affected203 at risk EG0020 affected93 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected288 at risk EG0011 affected203 at risk EG0020 affected93 at risk EG003

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

ID	Title	Description
BG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.
BG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
BG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
BG003	Patients With Baseline Viral Load Not Documented	Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment-naive Patients	Patients who were not pretreated with HIV therapy.	17	288	51	288
EG001	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.	12	203	33	203
EG002	Pretreated Patients, Baseline Viral Load > 50 Copies/mL	Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.	5	93	22	93
EG003	Patients With Baseline Viral Load Not Documented	Patients who could not be assigned to one of the three subgroups and had no documented viral load value.	0	21	3	21