Trial Outcomes & Findings for 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 (NCT NCT00979420)

Last Updated: 2014-06-30

Results Overview

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.

Recruitment status

COMPLETED

Primary outcome timeframe

Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Results posted on

2014-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	178	57	60	61
Overall Study COMPLETED	171	57	59	59
Overall Study NOT COMPLETED	7	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Not Documented Baseline reflects the last available documentation before start of treatment with Viramune
Overall Study Adverse Event	1	0	0
Overall Study Lack of Efficacy	3	1	1
Overall Study Other reasons not related to Viramune	3	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment-naive Patients n=178 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=61 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Total n=356 Participants Total of all reporting groups
Age, Continuous	50.85 Years STANDARD_DEVIATION 10.54 • n=5 Participants	54.21 Years STANDARD_DEVIATION 10.42 • n=7 Participants	51.02 Years STANDARD_DEVIATION 7.66 • n=5 Participants	53.69 Years STANDARD_DEVIATION 11.05 • n=4 Participants	51.91 Years STANDARD_DEVIATION 10.24 • n=21 Participants
Sex/Gender, Customized Male	142 Participants n=5 Participants	44 Participants n=7 Participants	41 Participants n=5 Participants	51 Participants n=4 Participants	278 Participants n=21 Participants
Sex/Gender, Customized Female	36 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	9 Participants n=4 Participants	77 Participants n=21 Participants
Sex/Gender, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Population: Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=86 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants 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
Change in log10 Viral Load From Baseline to Last Visit	-3.260 log10 copies/ml Full Range -5.61;2.25 • Interval -5.61 to 2.25	-0.099 log10 copies/ml Full Range -1.69;0.70 • Interval -1.69 to 0.7	-2.082 log10 copies/ml Full Range -5.82;0.40 • Interval -5.82 to 0.4	—

PRIMARY outcome

Timeframe: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Population: FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=86 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants 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
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit <50 copies/ml	83 Participants	55 Participants	55 Participants	—
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit >=50 copies/ml	3 Participants	2 Participants	5 Participants	—
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit Missing	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Population: FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=83 Participants 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 n=56 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants 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
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit	380 CD4+ cells/mm3 Full Range -323;1749 • Interval -323.0 to 1749.0	223.5 CD4+ cells/mm3 Full Range -328;1104 • Interval -328.0 to 1104.0	228 CD4+ cells/mm3 Full Range -360;1004 • Interval -360.0 to 1004.0	—

PRIMARY outcome

Timeframe: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Population: Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=63 Participants 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 n=34 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=33 Participants 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
Change in log10 Viral Load From Baseline to Last Visit	-3.284 log10 copies/ml Full Range -5.61;0.00 • Interval -5.61 to 0.0	0.000 log10 copies/ml Full Range -0.41;0.70 • Interval -0.41 to 0.7	-2.000 log10 copies/ml Full Range -5.824;0.40 • Interval -5.824 to 0.4	—

PRIMARY outcome

Timeframe: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Population: PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=63 Participants 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 n=34 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=33 Participants 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
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit <50 copies/ml	62 Participants	33 Participants	30 Participants	—
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit >=50 copies/ml	1 Participants	1 Participants	3 Participants	—

PRIMARY outcome

Timeframe: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Population: PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=61 Participants 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 n=33 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=33 Participants 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
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit	392 CD4+ cells/mm3 Full Range -323;1027 • Interval -323.0 to 1027.0	283 CD4+ cells/mm3 Full Range -234;1104 • Interval -234.0 to 1104.0	250 CD4+ cells/mm3 Full Range -266;987 • Interval -266.0 to 987.0	—

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.

Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=90 Participants 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 n=28 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=21 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=37 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade < Grade 1	11 Participants	7 Participants	4 Participants	2 Participants
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade Grade 1	26 Participants	8 Participants	4 Participants	18 Participants
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade Grade 2	40 Participants	10 Participants	9 Participants	8 Participants
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade Grade 3	13 Participants	3 Participants	4 Participants	9 Participants
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade Grade 4	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.

Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=76 Participants 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 n=23 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=18 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=33 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade < Grade 1	17 Participants	9 Participants	5 Participants	9 Participants
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade Grade 1	30 Participants	6 Participants	5 Participants	8 Participants
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade Grade 2	11 Participants	5 Participants	3 Participants	13 Participants
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade Grade 3	18 Participants	3 Participants	5 Participants	3 Participants
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade Grade 4	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=91 Participants 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 n=28 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=21 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=37 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade < Grade 1	72 Participants	27 Participants	17 Participants	26 Participants
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade Grade 2	15 Participants	1 Participants	2 Participants	4 Participants
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade Grade 3	3 Participants	0 Participants	1 Participants	4 Participants
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade Grade 4	1 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=175 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=59 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=59 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade < Grade 1	50 Participants	22 Participants	21 Participants	12 Participants
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade Grade 1	83 Participants	25 Participants	25 Participants	25 Participants
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade Grade 2	29 Participants	5 Participants	7 Participants	17 Participants
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade Grade 3	8 Participants	1 Participants	1 Participants	3 Participants
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade Grade 4	5 Participants	4 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=178 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=59 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=58 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade Grade 3	4 Participants	1 Participants	1 Participants	2 Participants
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade < Grade 1	94 Participants	32 Participants	27 Participants	28 Participants
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade Grade 1	68 Participants	17 Participants	27 Participants	22 Participants
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade Grade 2	12 Participants	7 Participants	3 Participants	4 Participants
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade Grade 4	0 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=178 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=59 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=58 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade < Grade 1	105 Participants	40 Participants	40 Participants	30 Participants
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade Grade 1	58 Participants	12 Participants	14 Participants	20 Participants
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade Grade 2	12 Participants	5 Participants	3 Participants	7 Participants
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade Grade 3	3 Participants	0 Participants	1 Participants	0 Participants
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade Grade 4	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=178 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=59 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade < Grade 1	152 Participants	51 Participants	50 Participants	49 Participants
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade Grade 1	13 Participants	3 Participants	5 Participants	3 Participants
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade Grade 2	2 Participants	0 Participants	2 Participants	1 Participants
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade Grade 3	1 Participants	0 Participants	0 Participants	1 Participants
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade Grade 4	10 Participants	3 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 185 months

Population: Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=178 Participants 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 n=56 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=59 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade < Grade 1	171 Participants	53 Participants	58 Participants	54 Participants
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade Grade 1	6 Participants	1 Participants	1 Participants	3 Participants
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade Grade 2	1 Participants	2 Participants	0 Participants	0 Participants
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade Grade 4	0 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: End of treatment, up to 185 months

Population: Treated set

Duration of intake of Viramune

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=178 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=61 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Duration of Intake of Viramune	131 months Interval 30.0 to 185.0	124 months Interval 43.0 to 149.0	131 months Interval 14.0 to 159.0	129 months Interval 105.0 to 161.0

SECONDARY outcome

Timeframe: Baseline

Population: Treated set

Participants with a history of therapy with antiretroviral medication.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=178 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=61 Participants Baseline reflects the last available documentation before start of treatment with Viramune
History of Therapy With Antiretroviral Medication Pre-treated	0 participants	57 participants	60 participants	61 participants
History of Therapy With Antiretroviral Medication Treatment-naive	178 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months

Population: PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years

The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=63 Participants 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 n=33 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=33 Participants 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
Course of Absolute CD4+ Cell Count	734 CD4+ cells/mm3 Interval 96.0 to 1526.0	669 CD4+ cells/mm3 Interval 189.0 to 1479.0	491 CD4+ cells/mm3 Interval 237.0 to 1326.0	—

SECONDARY outcome

Timeframe: Up to 185 months

Population: Treated set

Number of participants with drug related Adverse Events (AEs)

Outcome measures

Outcome measures
Measure	Treatment-naive Patients n=178 Participants 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 n=57 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n=60 Participants Baseline reflects the last available documentation before start of treatment with Viramune	Pre-treated Patients With Baseline HIV RNA Not Documented n=61 Participants Baseline reflects the last available documentation before start of treatment with Viramune
Number of Participants With Drug Related Adverse Events	0 participants	0 participants	1 participants	0 participants

Adverse Events

Viramune

Serious events: 35 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Viramune n=356 participants at risk
Cardiac disorders Acute myocardial infarction	0.28% 1/356 • 14 to 185 months
Cardiac disorders Bradycardia	0.28% 1/356 • 14 to 185 months
Cardiac disorders Cardiac valve disease	0.28% 1/356 • 14 to 185 months
Cardiac disorders Congestive cardiomyopathy	0.28% 1/356 • 14 to 185 months
Cardiac disorders Coronary artery disease	0.56% 2/356 • 14 to 185 months
Cardiac disorders Coronary artery occlusion	0.28% 1/356 • 14 to 185 months
Cardiac disorders Coronary artery stenosis	0.28% 1/356 • 14 to 185 months
Cardiac disorders Myocardial infarction	2.2% 8/356 • 14 to 185 months
Gastrointestinal disorders Abdominal pain lower	0.28% 1/356 • 14 to 185 months
Gastrointestinal disorders Pancreatitis	0.28% 1/356 • 14 to 185 months
Gastrointestinal disorders Subileus	0.28% 1/356 • 14 to 185 months
Gastrointestinal disorders Umbilical hernia	0.28% 1/356 • 14 to 185 months
Gastrointestinal disorders Vomiting	0.28% 1/356 • 14 to 185 months
Infections and infestations Appendicitis	0.56% 2/356 • 14 to 185 months
Infections and infestations Pneumonia pneumococcal	0.28% 1/356 • 14 to 185 months
Infections and infestations Syphilis	0.28% 1/356 • 14 to 185 months
Injury, poisoning and procedural complications Accident	0.28% 1/356 • 14 to 185 months
Injury, poisoning and procedural complications Spinal cord injury	0.28% 1/356 • 14 to 185 months
Musculoskeletal and connective tissue disorders Osteonecrosis	0.28% 1/356 • 14 to 185 months
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.28% 1/356 • 14 to 185 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.28% 1/356 • 14 to 185 months
Nervous system disorders Cerebral haemorrhage	0.28% 1/356 • 14 to 185 months
Nervous system disorders Cerebral ischaemia	0.28% 1/356 • 14 to 185 months
Nervous system disorders Grand mal convulsion	0.28% 1/356 • 14 to 185 months
Nervous system disorders Headache	0.28% 1/356 • 14 to 185 months
Nervous system disorders Hemiparesis	0.28% 1/356 • 14 to 185 months
Pregnancy, puerperium and perinatal conditions Abortion	0.56% 2/356 • 14 to 185 months
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.4% 5/356 • 14 to 185 months
Pregnancy, puerperium and perinatal conditions Premature baby	0.28% 1/356 • 14 to 185 months
Psychiatric disorders Substance abuse	0.28% 1/356 • 14 to 185 months
Psychiatric disorders Suicide attempt	0.56% 2/356 • 14 to 185 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.28% 1/356 • 14 to 185 months
Surgical and medical procedures Caesarean section	2.0% 7/356 • 14 to 185 months
Vascular disorders Venous thrombosis	0.56% 2/356 • 14 to 185 months

Other adverse events

Other adverse events
Measure	Viramune n=356 participants at risk
Gastrointestinal disorders Diarrhoea	5.9% 21/356 • 14 to 185 months
Infections and infestations Bronchitis	5.6% 20/356 • 14 to 185 months
Vascular disorders Hypertension	7.0% 25/356 • 14 to 185 months

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER