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Completed

NCT Number: NCT01134939

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 23, Aachen, Germany

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About this study

Time Perspective:

retro- and prospective

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Changes in the Viral Load After 36 Months From Baseline

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

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

    Time frame: 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. .

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 2, 2010
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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