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

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ClinicalTrials.gov Identifier: NCT00876733
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV Infections
Enrollment 605
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description Patients who were not pretreated with HIV therapy. Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Period Title: Overall Study
Started 288 203 93 21
Completed 197 161 63 14
Not Completed 91 42 30 7
Reason Not Completed
Adverse Event             34             20             10             3
Lack of Efficacy             17             9             10             1
Lost to Follow-up             26             10             3             2
Data not available             14             3             7             1
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented Total
Hide Arm/Group Description Patients who were not pretreated with HIV therapy. Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Patients who could not be assigned to one of the three subgroups and had no documented viral load value. Total of all reporting groups
Overall Number of Baseline Participants 288 203 93 21 605
Hide Baseline Analysis Population Description
Treated set (TS): This patient set includes all HIV-1 infected patients who were dispensed Viramune® and were documented to have taken at least one dose of Viramune®and of a antiretroviral combination partner.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 288 participants 203 participants 93 participants 21 participants 605 participants
40.2  (9.9) 43.8  (9.6) 40.9  (9.4) 43.6  (7.8) 41.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 203 participants 93 participants 21 participants 605 participants
Female
32
  11.1%
29
  14.3%
6
   6.5%
0
   0.0%
67
  11.1%
Male
256
  88.9%
174
  85.7%
87
  93.5%
21
 100.0%
538
  88.9%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Hide Description Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
Time Frame 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 288 203 93 21
Measure Type: Number
Unit of Measure: participants
Patients with any AE 168 110 51 10
Patients with serious AEs 17 12 5 0
2.Secondary Outcome
Title Changes in the Viral Load After 12 Months From Baseline.
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS with values for viral load at baseline and after 12 months.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 238 181 78 0
Mean (Standard Deviation)
Unit of Measure: Log10 copies/ml
-3.3  (1.3) -0.1  (0.8) -1.9  (1.7)
3.Secondary Outcome
Title Changes in the Viral Load After 36 Months From Baseline.
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS with values for viral load at baseline and after 36 months.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 231 185 74 0
Mean (Standard Deviation)
Unit of Measure: Log10 copies/ml
-3.4  (1.4) -0.2  (1.1) -2.1  (1.8)
4.Secondary Outcome
Title Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS with values for CD4+ at baseline and after 12 months.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 238 178 76 2
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
188.7  (165.0) 54.6  (145.3) 82.8  (269.5) 128.0  (223.4)
5.Secondary Outcome
Title Changes in the CD4+ Cell Count After 36 Months From Baseline.
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS with values for CD4+ at baseline and after 36 months.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 230 181 72 2
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
223.7  (200.4) 2.8  (221.3) 116.0  (317.7) 63.5  (152.0)
6.Secondary Outcome
Title Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 139 128 42 5
Mean (Standard Deviation)
Unit of Measure: mg/dL
25.2  (36.2) -3.0  (43.2) 15.8  (32.8) 16.4  (9.7)
7.Secondary Outcome
Title Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 95 76 26 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
12.7  (14.3) 4.2  (15.0) 10.9  (14.9) -13.2  (29.1)
8.Secondary Outcome
Title Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 95 75 25 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
12.1  (29.6) 2.4  (35.7) 14.4  (30.5) 13.6  (10.1)
9.Secondary Outcome
Title Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Triglycerides at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 139 130 38 5
Mean (Standard Deviation)
Unit of Measure: mg/dL
7.9  (106.7) -61.6  (180.2) -24.0  (78.9) 16.3  (47.2)
10.Secondary Outcome
Title Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 136 134 44 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.2  (20.6) -3.6  (16.9) 0.3  (24.9) -8.4  (9.2)
11.Secondary Outcome
Title Changes in the Laboratory Data (ALT) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for ALT at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 175 152 49 7
Mean (Standard Deviation)
Unit of Measure: U/L
5.6  (20.5) 10.2  (28.8) 7.0  (28.4) 9.7  (33.0)
12.Secondary Outcome
Title Changes in the Laboratory Data (AST) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for AST at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 173 146 48 7
Mean (Standard Deviation)
Unit of Measure: U/L
1.7  (19.1) 4.4  (24.7) 3.0  (20.9) 8.3  (32.4)
13.Secondary Outcome
Title Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Gamma GT at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 175 152 49 7
Mean (Standard Deviation)
Unit of Measure: U/L
32.9  (72.4) 25.4  (57.7) 23.7  (62.3) 9.1  (42.6)
14.Secondary Outcome
Title Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Creatinine at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 176 152 47 7
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.0  (0.1) 0.0  (0.1) 0.0  (0.1) 0.0  (0.2)
15.Secondary Outcome
Title Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline
Hide Description 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.
Time Frame Baseline and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 177 147 45 7
Mean (Standard Deviation)
Unit of Measure: g/dL
0.6  (1.1) 0.3  (1.2) 0.3  (0.9) 0.5  (1.1)
16.Secondary Outcome
Title Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 82 66 25 2
Mean (Standard Deviation)
Unit of Measure: mg/dL
24.1  (39.0) 2.0  (44.4) 24.2  (42.4) 41.1  (12.9)
17.Secondary Outcome
Title Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 53 42 15 2
Mean (Standard Deviation)
Unit of Measure: mg/dL
11.0  (21.4) 4.4  (20.7) 11.1  (11.9) -19.6  (38.7)
18.Secondary Outcome
Title Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 53 40 15 2
Mean (Standard Deviation)
Unit of Measure: mg/dL
12.4  (25.8) 15.8  (38.1) 23.8  (44.7) 22.7  (27.9)
19.Secondary Outcome
Title Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Triglycerides at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 83 67 25 1
Mean (Standard Deviation)
Unit of Measure: mg/dL
-3.4  (91.3) -73.7  (252.6) -17.2  (98.0) 34.2
20.Secondary Outcome
Title Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 78 71 23 1
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.6  (27.2) 0.0  (19.9) 0.7  (36.4) -7.2
21.Secondary Outcome
Title Changes in the Laboratory Data (ALT) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for ALT at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 103 76 30 3
Mean (Standard Deviation)
Unit of Measure: U/L
16.2  (107.1) 4.0  (33.7) 11.8  (27.7) 5.2  (26.1)
22.Secondary Outcome
Title Changes in the Laboratory Data (AST) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for AST at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 100 75 29 3
Mean (Standard Deviation)
Unit of Measure: U/L
7.3  (75.3) 0.1  (24.6) 5.5  (27.1) -2.7  (19.6)
23.Secondary Outcome
Title Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Gamma GT at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 104 76 30 3
Mean (Standard Deviation)
Unit of Measure: U/L
52.3  (102.5) 45.0  (112.6) 50.3  (50.3) 12.9  (48.1)
24.Secondary Outcome
Title Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Creatinine at baseline and at month 12.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 103 74 30 3
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.0  (0.2) 0.0  (0.1) 0.0  (0.1) 0.0  (0.1)
25.Secondary Outcome
Title Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
Hide Description 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.
Time Frame Baseline and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description:
Patients who were not pretreated with HIV therapy.
Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 103 73 30 3
Mean (Standard Deviation)
Unit of Measure: g/dL
0.7  (0.9) 0.2  (1.2) 0.5  (1.4) -0.1  (1.6)
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Hide Arm/Group Description Patients who were not pretreated with HIV therapy. Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
All-Cause Mortality
Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/288 (5.90%)   12/203 (5.91%)   5/93 (5.38%)   0/21 (0.00%) 
Gastrointestinal disorders         
Colitis  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Diarrhoea  1  2/288 (0.69%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Diverticulum intestinal  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Inguinal hernia  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Intestinal stenosis  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Large intestine perforation  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Nausea  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Vomiting  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
General disorders         
Chest pain  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Device occlusion  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Local swelling  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Tenderness  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Hepatobiliary disorders         
Hepatotoxicity  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Infections and infestations         
Acute hepatitis C  1  1/288 (0.35%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Appendicitis  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Bronchiolitis  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Bronchopneumonia  1  0/288 (0.00%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Cellulitis  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Herpes zoster  1  1/288 (0.35%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Meningoencephalitis herpetic  1  0/288 (0.00%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Myelitis  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Peritonitis  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Sepsis  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Urinary tract infection  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications         
Joint dislocation  1  0/288 (0.00%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Investigations         
Biopsy  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Hepatic enzyme abnormal  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Transaminases increased  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Juvenile idiopathic arthritis  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Pain in extremity  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anogenital warts  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Hypopharyngeal cancer  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Hypopharyngeal cancer recurrent  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
Cerebral infarction  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Convulsion  1  0/288 (0.00%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion incomplete  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Psychiatric disorders         
Acute stress disorder  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Alcoholism  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Anxiety disorder  1  0/288 (0.00%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Depression  1  0/288 (0.00%)  0/203 (0.00%)  2/93 (2.15%)  0/21 (0.00%) 
Psychotic disorder  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Somatoform disorder  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Renal and urinary disorders         
Acute prerenal failure  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Reproductive system and breast disorders         
Epididymitis  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Pelvic pain  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary hypertension  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Surgical and medical procedures         
Bursa removal  1  0/288 (0.00%)  0/203 (0.00%)  1/93 (1.08%)  0/21 (0.00%) 
Laparoscopic surgery  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Laser therapy  1  1/288 (0.35%)  0/203 (0.00%)  0/93 (0.00%)  0/21 (0.00%) 
Vascular disorders         
Peripheral arterial occlusive disease  1  0/288 (0.00%)  1/203 (0.49%)  0/93 (0.00%)  0/21 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment-naive Patients Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Patients, Baseline Viral Load > 50 Copies/mL Patients With Baseline Viral Load Not Documented
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/288 (17.71%)   33/203 (16.26%)   22/93 (23.66%)   3/21 (14.29%) 
Gastrointestinal disorders         
Diarrhoea  1  16/288 (5.56%)  14/203 (6.90%)  7/93 (7.53%)  2/21 (9.52%) 
Infections and infestations         
Bronchitis  1  14/288 (4.86%)  21/203 (10.34%)  9/93 (9.68%)  1/21 (4.76%) 
Nasopharyngitis  1  30/288 (10.42%)  13/203 (6.40%)  15/93 (16.13%)  1/21 (4.76%) 
Upper respiratory tract infection  1  15/288 (5.21%)  3/203 (1.48%)  3/93 (3.23%)  0/21 (0.00%) 
Investigations         
Transaminase increased  1  16/288 (5.56%)  3/203 (1.48%)  2/93 (2.15%)  0/21 (0.00%) 
Vascular disorders         
Hypertension  1  8/288 (2.78%)  6/203 (2.96%)  2/93 (2.15%)  2/21 (9.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
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.
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00876733     History of Changes
Other Study ID Numbers: 1100.1524
First Submitted: March 20, 2009
First Posted: April 7, 2009
Results First Submitted: December 27, 2014
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015