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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

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ClinicalTrials.gov Identifier: NCT00979420
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : August 16, 2012
Last Update Posted : June 30, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Retrospective
Condition HIV Infections
Enrollment [Not Specified]
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 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
Hide Arm/Group Description Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune Baseline reflects the last available documentation before start of treatment with Viramune Baseline reflects the last available documentation before start of treatment with Viramune
Period Title: Overall Study
Started 178 57 60 61
Completed 171 57 59 59
Not Completed 7 0 1 2
Reason Not Completed
Adverse Event             1             0             0             0
Lack of Efficacy             3             0             1             1
Other reasons not related to Viramune             3             0             0             1
Arm/Group Title 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
Hide Arm/Group Description Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune Baseline reflects the last available documentation before start of treatment with Viramune Baseline reflects the last available documentation before start of treatment with Viramune Baseline reflects the last available documentation before start of treatment with Viramune Total of all reporting groups
Overall Number of Baseline Participants 178 57 60 61 356
Hide Baseline Analysis Population Description
Treated set - all patients receiving at least one dose of study medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants 57 participants 60 participants 61 participants 356 participants
50.85  (10.54) 54.21  (10.42) 51.02  (7.66) 53.69  (11.05) 51.91  (10.24)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 178 participants 57 participants 60 participants 61 participants 356 participants
Male 142 44 41 51 278
Female 36 13 19 9 77
Missing 0 0 0 1 1
1.Primary Outcome
Title Change in log10 Viral Load From Baseline to Last Visit
Hide Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment-naive Patients Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 86 57 60
Median (Full Range)
Unit of Measure: log10 copies/ml
-3.260
(-5.61 to 2.25)
-0.099
(-1.69 to 0.70)
-2.082
(-5.82 to 0.40)
2.Primary Outcome
Title Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
Hide Description [Not Specified]
Time Frame Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment-naive Patients Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 86 57 60
Measure Type: Number
Unit of Measure: Participants
<50 copies/ml 83 55 55
>=50 copies/ml 3 2 5
Missing 0 0 0
3.Primary Outcome
Title Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
Hide Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment-naive Patients Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 83 56 60
Median (Full Range)
Unit of Measure: CD4+ cells/mm3
380
(-323 to 1749)
223.5
(-328 to 1104)
228
(-360 to 1004)
4.Primary Outcome
Title Change in log10 Viral Load From Baseline to Last Visit
Hide Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.
Arm/Group Title Treatment-naive Patients Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 63 34 33
Median (Full Range)
Unit of Measure: log10 copies/ml
-3.284
(-5.61 to 0.00)
0.000
(-0.41 to 0.70)
-2.000
(-5.824 to 0.40)
5.Primary Outcome
Title Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
Hide Description [Not Specified]
Time Frame Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.
Arm/Group Title Treatment-naive Patients Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 63 34 33
Measure Type: Number
Unit of Measure: Participants
<50 copies/ml 62 33 30
>=50 copies/ml 1 1 3
6.Primary Outcome
Title Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
Hide Description 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.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.
Arm/Group Title Treatment-naive Patients Pre-treated Patients With Baseline HIV RNA<50 Copies/ml Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 61 33 33
Median (Full Range)
Unit of Measure: CD4+ cells/mm3
392
(-323 to 1027)
283
(-234 to 1104)
250
(-266 to 987)
7.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 90 28 21 37
Measure Type: Number
Unit of Measure: Participants
< Grade 1 11 7 4 2
Grade 1 26 8 4 18
Grade 2 40 10 9 8
Grade 3 13 3 4 9
Grade 4 0 0 0 0
8.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 76 23 18 33
Measure Type: Number
Unit of Measure: Participants
< Grade 1 17 9 5 9
Grade 1 30 6 5 8
Grade 2 11 5 3 13
Grade 3 18 3 5 3
Grade 4 0 0 0 0
9.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 91 28 21 37
Measure Type: Number
Unit of Measure: Participants
< Grade 1 72 27 17 26
Grade 1 0 0 0 0
Grade 2 15 1 2 4
Grade 3 3 0 1 4
Grade 4 1 0 1 3
10.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 175 57 59 59
Measure Type: Number
Unit of Measure: Participants
< Grade 1 50 22 21 12
Grade 1 83 25 25 25
Grade 2 29 5 7 17
Grade 3 8 1 1 3
Grade 4 5 4 5 2
11.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 178 57 59 58
Measure Type: Number
Unit of Measure: Participants
< Grade 1 94 32 27 28
Grade 1 68 17 27 22
Grade 2 12 7 3 4
Grade 3 4 1 1 2
Grade 4 0 0 1 2
12.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 178 57 59 58
Measure Type: Number
Unit of Measure: Participants
< Grade 1 105 40 40 30
Grade 1 58 12 14 20
Grade 2 12 5 3 7
Grade 3 3 0 1 0
Grade 4 0 0 1 1
13.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 178 57 60 59
Measure Type: Number
Unit of Measure: Participants
< Grade 1 152 51 50 49
Grade 1 13 3 5 3
Grade 2 2 0 2 1
Grade 3 1 0 0 1
Grade 4 10 3 3 5
14.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade
Hide Description 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.
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 178 56 60 59
Measure Type: Number
Unit of Measure: Participants
< Grade 1 171 53 58 54
Grade 1 6 1 1 3
Grade 2 1 2 0 0
Grade 3 0 0 0 0
Grade 4 0 0 1 2
15.Secondary Outcome
Title Duration of Intake of Viramune
Hide Description Duration of intake of Viramune
Time Frame End of treatment, up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 178 57 60 61
Median (Full Range)
Unit of Measure: months
131
(30 to 185)
124
(43 to 149)
131
(14 to 159)
129
(105 to 161)
16.Secondary Outcome
Title History of Therapy With Antiretroviral Medication
Hide Description Participants with a history of therapy with antiretroviral medication.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 178 57 60 61
Measure Type: Number
Unit of Measure: participants
Treatment-naive 178 0 0 0
Pre-treated 0 57 60 61
17.Secondary Outcome
Title Course of Absolute CD4+ Cell Count
Hide Description The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.
Time Frame Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years
Arm/Group Title Treatment-naive Patients Pre-treated Patients With Baseline HIV RNA <50 Copies/ml Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 63 33 33
Median (Full Range)
Unit of Measure: CD4+ cells/mm3
734
(96 to 1526)
669
(189 to 1479)
491
(237 to 1326)
18.Secondary Outcome
Title Number of Participants With Drug Related Adverse Events
Hide Description Number of participants with drug related Adverse Events (AEs)
Time Frame Up to 185 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title 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
Hide Arm/Group Description:
Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Baseline reflects the last available documentation before start of treatment with Viramune
Overall Number of Participants Analyzed 178 57 60 61
Measure Type: Number
Unit of Measure: participants
0 0 1 0
Time Frame 14 to 185 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Viramune
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Viramune
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Viramune
Affected / at Risk (%)
Total   35/356 (9.83%) 
Cardiac disorders   
Acute myocardial infarction  1  1/356 (0.28%) 
Bradycardia  1  1/356 (0.28%) 
Cardiac valve disease  1  1/356 (0.28%) 
Congestive cardiomyopathy  1  1/356 (0.28%) 
Coronary artery disease  1  2/356 (0.56%) 
Coronary artery occlusion  1  1/356 (0.28%) 
Coronary artery stenosis  1  1/356 (0.28%) 
Myocardial infarction  1  8/356 (2.25%) 
Gastrointestinal disorders   
Abdominal pain lower  1  1/356 (0.28%) 
Pancreatitis  1  1/356 (0.28%) 
Subileus  1  1/356 (0.28%) 
Umbilical hernia  1  1/356 (0.28%) 
Vomiting  1  1/356 (0.28%) 
Infections and infestations   
Appendicitis  1  2/356 (0.56%) 
Pneumonia pneumococcal  1  1/356 (0.28%) 
Syphilis  1  1/356 (0.28%) 
Injury, poisoning and procedural complications   
Accident  1  1/356 (0.28%) 
Spinal cord injury  1  1/356 (0.28%) 
Musculoskeletal and connective tissue disorders   
Osteonecrosis  1  1/356 (0.28%) 
Rotator cuff syndrome  1  1/356 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  1/356 (0.28%) 
Nervous system disorders   
Cerebral haemorrhage  1  1/356 (0.28%) 
Cerebral ischaemia  1  1/356 (0.28%) 
Grand mal convulsion  1  1/356 (0.28%) 
Headache  1  1/356 (0.28%) 
Hemiparesis  1  1/356 (0.28%) 
Pregnancy, puerperium and perinatal conditions   
Abortion  1  2/356 (0.56%) 
Abortion spontaneous  1  5/356 (1.40%) 
Premature baby  1  1/356 (0.28%) 
Psychiatric disorders   
Substance abuse  1  1/356 (0.28%) 
Suicide attempt  1  2/356 (0.56%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/356 (0.28%) 
Surgical and medical procedures   
Caesarean section  1  7/356 (1.97%) 
Vascular disorders   
Venous thrombosis  1  2/356 (0.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Viramune
Affected / at Risk (%)
Total   60/356 (16.85%) 
Gastrointestinal disorders   
Diarrhoea  1  21/356 (5.90%) 
Infections and infestations   
Bronchitis  1  20/356 (5.62%) 
Vascular disorders   
Hypertension  1  25/356 (7.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00979420     History of Changes
Other Study ID Numbers: 1100.1535
First Submitted: September 16, 2009
First Posted: September 18, 2009
Results First Submitted: May 30, 2012
Results First Posted: August 16, 2012
Last Update Posted: June 30, 2014