Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune

Participant Flow:   Overall Study

	Treatment-naive Patients	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Pre-treated Patients With Baseline HIV RNA Not Documented
STARTED	178	57	60	61
COMPLETED	171	57	59	59
NOT COMPLETED	7	0	1	2
Adverse Event	1	0	0	0
Lack of Efficacy	3	0	1	1
Other reasons not related to Viramune	3	0	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set - all patients receiving at least one dose of study medication

Reporting Groups

	Description
Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune
Total	Total of all reporting groups

Baseline Measures

	Treatment-naive Patients	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Pre-treated Patients With Baseline HIV RNA Not Documented	Total
Overall Participants Analyzed  [Units: Participants]	178	57	60	61	356
Age  [Units: Years] Mean (Standard Deviation)	50.85  (10.54)	54.21  (10.42)	51.02  (7.66)	53.69  (11.05)	51.91  (10.24)
Gender, Customized  [Units: Participants]
Male	142	44	41	51	278
Female	36	13	19	9	77
Missing	0	0	0	1	1

1.  Primary:

Change in log10 Viral Load From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

2.  Primary:

Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit   [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

3.  Primary:

Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

4.  Primary:

Change in log10 Viral Load From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

5.  Primary:

Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit   [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

6.  Primary:

Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

7.  Secondary:

Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade   [ Time Frame: Up to 185 months ]

8.  Secondary:

Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

9.  Secondary:

Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

10.  Secondary:

Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

11.  Secondary:

Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

12.  Secondary:

Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

13.  Secondary:

Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

14.  Secondary:

Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade   [ Time Frame: Up to 185 months ]

15.  Secondary:

Duration of Intake of Viramune   [ Time Frame: End of treatment, up to 185 months ]

16.  Secondary:

History of Therapy With Antiretroviral Medication   [ Time Frame: Baseline ]

17.  Secondary:

Course of Absolute CD4+ Cell Count   [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months ]

18.  Secondary:

Number of Participants With Drug Related Adverse Events   [ Time Frame: Up to 185 months ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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