Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01134939

Enrollment

265

Registered

2010-06-02

Start date

2010-05-31

Completion date

2013-12-31

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

Detailed description

Time Perspective: retro- and prospective

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC

Exclusion criteria

The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients With Virologic Response (VR) After 36 Months	36 months	VR is defined as HIV viral load of \< 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml.

Secondary

Measure	Time frame	Description
Changes in the CD4+ Cell Count After 36 Months From Baseline	Baseline and 36 months	The change in the Cluster of differentiation 4 (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.
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Viral Load After 36 Months From Baseline	Baseline and 36 months	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.
Changes in the Laboratory Data ( ALT) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (AST) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline	Baseline and 36 months	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. .
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline	Baseline and 36 months	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. .

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Treatment-naive Female Patients Female patients who were not pretreated with HIV therapy.	59
Treatment-naive Male Patients Male patients who were not pretreated with HIV therapy.	42
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.	51
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.	46
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Female patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.	33
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Male patients switching from a virologically ineffective treatment regimen, viral load \>50 copies/mL.	14
Female Patients, Baseline Viral Load Not Documented Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.	19
Male Patients, Baseline Viral Load Not Documented Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.	1
Total	265

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Overall Study	Adverse Event	9	3	4	5	5	5	1
Overall Study	Death	0	1	0	0	0	0	0
Overall Study	Lack of Efficacy	2	5	1	0	3	0	1
Overall Study	Lost to Follow-up	2	3	0	1	2	1	0
Overall Study	Termination page not available	4	6	5	8	0	3	7

Baseline characteristics

Characteristic	Treatment-naive Female Patients	Treatment-naive Male Patients	Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL	Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL	Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL	Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL	Female Patients, Baseline Viral Load Not Documented	Male Patients, Baseline Viral Load Not Documented	Total
Age, Continuous	38.1 years STANDARD_DEVIATION 9.7	39.2 years STANDARD_DEVIATION 11.2	39.2 years STANDARD_DEVIATION 9.1	44.2 years STANDARD_DEVIATION 8.1	36.3 years STANDARD_DEVIATION 8	43.2 years STANDARD_DEVIATION 10.7	38.9 years STANDARD_DEVIATION 8.9	50.0 years	39.7 years STANDARD_DEVIATION 9.6
Sex: Female, Male Female	59 Participants	0 Participants	51 Participants	0 Participants	33 Participants	0 Participants	19 Participants	0 Participants	162 Participants
Sex: Female, Male Male	0 Participants	42 Participants	0 Participants	46 Participants	0 Participants	14 Participants	0 Participants	1 Participants	103 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	46 / 101	56 / 97	24 / 47	8 / 20
serious Total, serious adverse events	7 / 101	10 / 97	4 / 47	1 / 20

Outcome results

Primary

Number of Patients With Virologic Response (VR) After 36 Months

VR is defined as HIV viral load of \< 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml.

Time frame: 36 months

Population: 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.

Arm	Measure	Value (NUMBER)
Treatment-naive Female Patients	Number of Patients With Virologic Response (VR) After 36 Months	44 participants
Treatment-naive Male Patients	Number of Patients With Virologic Response (VR) After 36 Months	30 participants
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL	Number of Patients With Virologic Response (VR) After 36 Months	46 participants
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL	Number of Patients With Virologic Response (VR) After 36 Months	40 participants
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL	Number of Patients With Virologic Response (VR) After 36 Months	25 participants
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL	Number of Patients With Virologic Response (VR) After 36 Months	6 participants
Female Patients, Baseline Viral Load Not Documented	Number of Patients With Virologic Response (VR) After 36 Months	16 participants
Male Patients, Baseline Viral Load Not Documented	Number of Patients With Virologic Response (VR) After 36 Months	1 participants

Secondary

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

The change in the Cluster of differentiation 4 (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.