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Completed

NCT Number: NCT00876733

Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 14, Aachen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male and female
  • 18 years or older
  • written informed consent
  • The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC

Exclusion criteria

  • Pregnant patients
  • The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC

Treatment and study plan

Primary outcomes

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

    Time frame: 36 months

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

Secondary outcomes

  1. Changes in the Viral Load After 12 Months From Baseline.

    Time frame: Baseline and 12 months

    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.

  2. 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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 36 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

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

    Time frame: Baseline and 12 months

    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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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 ARV in HIV Infected Patients

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 7, 2009
Registry last updated
Jan 16, 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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