Observational Non-interventional Study With Viramune® in... | NCT00543803

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment	The change in alanine aminotransferase (ALT) from baseline to the last value in treatment	from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment	The change in asparate aminotransferase (AST) from baseline to the last value in treatment	from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment	The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment	from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Creatinine to Last Value on Treatment	The change in Creatinine from baseline to the last value in treatment	from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment	The change in total cholesterol from baseline to the last value in treatment	from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment	The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment	from baseline to last value on treatment in between 36 months

Secondary Outcomes

Measure	Description	Time Frame
Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment	For calculation of this measure switch patients are included in the total which had no viral load decrease.	from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in CD4+ Count to Last Value on Treatment

Eligibility Module

Eligibility Criteria

Inclusion criteria

male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Exclusion criteria

Age < 18 years
Pregnant female patients
Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) > 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised < 5 ULN.
Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT > 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Aachen			Germany
1100.1492.1 Boehringer Ingelheim Investigational Site

Label	URL
Related Info	View source

ID	Title	Description
FG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

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

Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment

The change in alanine aminotransferase (ALT) from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

IU/L

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000295

Title

Denominators

Categories

Title	Measurements
	OG0001.0(-3.0 to 7.0)

Primary

Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment

The change in asparate aminotransferase (AST) from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

IU/L

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000

Primary

Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment

The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

IU/L

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000

Primary

Summary of Change From Baseline in Creatinine to Last Value on Treatment

The change in Creatinine from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

mg/dl

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000312

Primary

Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment

The change in total cholesterol from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

mg/dl

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000262

Primary

Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment

The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

mg/dl

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000

Primary

Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment

The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

mg/dl

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000

Primary

Summary of Change From Baseline in Triglycerides to Last Value on Treatment

The change in triglycerides from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

mg/dl

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000267

Primary

Summary of Change From Baseline in Glucose to Last Value on Treatment

The change in Glucose from baseline to the last value in treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

mg/dl

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000276

Secondary

Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment

For calculation of this measure switch patients are included in the total which had no viral load decrease.

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

(log10 copies) / ml

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000

Secondary

Summary of Change From Baseline in CD4+ Count to Last Value on Treatment

FAS- All patients were considered for the full analysis set.

Posted

Median

Inter-Quartile Range

(cells) / mm^3

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000312

Secondary

Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator

Total number of patients with investigator defined non-serious drug-related AEs was reported.

FAS- All patients were considered for the full analysis set.

Posted

Number

participants

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd

Units	Counts
Participants	OG000334

Secondary

Investigator's Global Clinical Assessment of Patient General Health Status

Investigators opinion of patients general health condition at baseline versus last evaluation on treatment

FAS- All patients were considered for the full analysis set.

Posted

Number

participants

from baseline to last value on treatment in between 36 months

ID	Title	Description
OG000	Evaluation Assessment at Baseline	Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
OG001	Last Evaluation Assessment on Treatment	Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Condition aggravated	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Disease recurrence	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Jaundice	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Anogenital warts	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Meningitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Pilonidal cyst	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Oligodendroglioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Cerebellar ataxia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Epilepsy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Nervous system disorder	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Neuromyopathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Nystagmus	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Drug abuse	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected334 at risk
Debridement	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 affected334 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