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Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

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ClinicalTrials.gov Identifier: NCT01134939
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : January 21, 2015
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort
Condition HIV Infections
Enrollment 265
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment-naive Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description Female patients who were not pretreated with HIV therapy. Male patients who were not pretreated with HIV therapy. Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Period Title: Overall Study
Started 59 42 51 46 33 14 19 1
Completed 42 24 41 32 23 5 10 1
Not Completed 17 18 10 14 10 9 9 0
Reason Not Completed
Adverse Event             9             3             4             5             5             5             1             0
Lack of Efficacy             2             5             1             0             3             0             1             0
Lost to Follow-up             2             3             0             1             2             1             0             0
Death             0             1             0             0             0             0             0             0
Termination page not available             4             6             5             8             0             3             7             0
Arm/Group Title Treatment-naive Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented Total
Hide Arm/Group Description Female patients who were not pretreated with HIV therapy. Male patients who were not pretreated with HIV therapy. Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Female patients who could not be assigned to one of the three subgroups and had no documented viral load value. Male 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 59 42 51 46 33 14 19 1 265
Hide Baseline Analysis Population Description
Treated Set (TS): This patient set includes all HIV-1 infected patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment and of an antiretroviral combination partner.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 42 participants 51 participants 46 participants 33 participants 14 participants 19 participants 1 participants 265 participants
38.1  (9.7) 39.2  (11.2) 39.2  (9.1) 44.2  (8.1) 36.3  (8.0) 43.2  (10.7) 38.9  (8.9) 50.0 39.7  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 42 participants 51 participants 46 participants 33 participants 14 participants 19 participants 1 participants 265 participants
Female
59
 100.0%
0
   0.0%
51
 100.0%
0
   0.0%
33
 100.0%
0
   0.0%
19
 100.0%
0
   0.0%
162
  61.1%
Male
0
   0.0%
42
 100.0%
0
   0.0%
46
 100.0%
0
   0.0%
14
 100.0%
0
   0.0%
1
 100.0%
103
  38.9%
1.Primary Outcome
Title Number of Patients With Virologic Response (VR) After 36 Months
Hide Description

VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart.

A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml.

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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 58 42 51 46 33 14 18 1
Measure Type: Number
Unit of Measure: participants
44 30 46 40 25 6 16 1
2.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 45 36 51 45 30 12 0 0
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
-2.7  (1.2) -2.7  (1.5) -0.3  (0.7) -0.3  (0.5) -2.4  (1.7) -1.2  (1.3)
3.Secondary Outcome
Title Changes in the CD4+ Cell Count After 36 Months From Baseline
Hide Description The change in the Cluster of differentiation 4 (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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 44 35 50 45 30 12 1 1
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
253.3  (209.9) 216.9  (191.4) 85.9  (196.6) 39.8  (193.6) 246.4  (271.2) 137.1  (301.8) 115.0 342.0
4.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 14 5 9 5 13 1 2 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
3.9  (61.0) 32.9  (20.8) -11.5  (60.3) 43.0  (37.6) -2.0  (34.5) 26.0 [1]   (NA) 74.0  (32.5)
[1]
N=1
5.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 7 3 6 5 6 0 2 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
15.6  (15.5) 20.2  (1.0) 9.3  (17.1) -26.5  (102.8) 18.9  (13.1) 5.0  (21.2)
6.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 7 3 6 5 6 0 2 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.3  (30.3) 27.8  (13.9) 3.8  (24.3) 5.0  (30.4) -9.3  (27.8) 73.0  (42.4)
7.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 14 5 9 6 13 1 2 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
-18.5  (63.1) -16.6  (32.3) -71.8  (102.2) -31.7  (90.8) -53.3  (53.7) 160 [1]   (NA) -5.5  (50.2)
[1]
N=1
8.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 14 5 11 4 15 1 3 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.4  (29.1) 5.3  (18.6) 0.2  (22.2) 3.9  (7.2) 7.2  (13.8) -27.5 [1]   (NA) -17.3  (38.5)
[1]
N=1
9.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 13 7 9 9 16 2 3 0
Mean (Standard Deviation)
Unit of Measure: U/L
1.3  (8.6) 7.5  (13.8) 7.7  (11.7) 6.1  (18.7) 0.0  (15.4) 12.6  (34.8) 6.3  (11.7)
10.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 the AST at baseline and at month 36.
Arm/Group Title Treatment-naive Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 13 7 8 9 16 2 3 0
Mean (Standard Deviation)
Unit of Measure: U/L
1.4  (9.5) 3.0  (11.2) 1.4  (5.6) 0.4  (10.3) -1.7  (13.5) -0.8  (17.3) 0.7  (6.1)
11.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 14 7 9 9 16 2 3 0
Mean (Standard Deviation)
Unit of Measure: U/L
22.7  (26.9) 25.2  (15.4) 7.0  (25.7) 4.8  (111.7) 20.9  (31.6) 40.8  (61.9) -4.7  (10.5)
12.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 36.
Arm/Group Title Treatment-naive Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 13 7 10 9 16 2 3 0
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.0  (0.2) 0.1  (0.1) -0.1  (0.2) -0.1  (0.1) 0.0  (0.1) -0.1  (0.0) 0.0  (0.1)
13.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 Female Patients Treatment-naive Male Patients Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL Female Patients, Baseline Viral Load Not Documented Male Patients, Baseline Viral Load Not Documented
Hide Arm/Group Description:
Female patients who were not pretreated with HIV therapy.
Male patients who were not pretreated with HIV therapy.
Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
Overall Number of Participants Analyzed 14 7 9 9 16 2 3 0
Mean (Standard Deviation)
Unit of Measure: g/dL
0.8  (1.3) 0.4  (0.8) 0.1  (1.1) 0.8  (1.0) 1.1  (1.1) 1.0  (2.4) 0.3  (1.8)
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 Female and male patients who were not pretreated with HIV therapy. Female and male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL. Female and male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL. Female and male 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   7/101 (6.93%)   10/97 (10.31%)   4/47 (8.51%)   1/20 (5.00%) 
Gastrointestinal disorders         
Abdominal pain lower  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Nausea  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Rectal prolapse  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Vomiting  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
General disorders         
Local swelling  1  0/101 (0.00%)  0/97 (0.00%)  1/47 (2.13%)  0/20 (0.00%) 
Swelling  1  0/101 (0.00%)  0/97 (0.00%)  1/47 (2.13%)  0/20 (0.00%) 
Hepatobiliary disorders         
Hepatotoxicity  1  0/101 (0.00%)  0/97 (0.00%)  1/47 (2.13%)  0/20 (0.00%) 
Jaundice  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Infections and infestations         
Erysipelas  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Gastrointestinal infection  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Herpes zoster  1  0/101 (0.00%)  0/97 (0.00%)  1/47 (2.13%)  0/20 (0.00%) 
Herpes zoster infection neurological  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Ophthalmic herpes zoster  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Tuberculosis  1  0/101 (0.00%)  0/97 (0.00%)  1/47 (2.13%)  0/20 (0.00%) 
Injury, poisoning and procedural complications         
Road traffic accident  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal pain  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Myopathy  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Osteonecrosis  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Invasive ductal breast carcinoma  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Uterine leiomyoma  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/101 (0.00%)  0/97 (0.00%)  1/47 (2.13%)  0/20 (0.00%) 
Transient ischaemic attack  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion missed  1  0/101 (0.00%)  0/97 (0.00%)  0/47 (0.00%)  1/20 (5.00%) 
Psychiatric disorders         
Completed suicide  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Depression  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Mental disorder  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Psychiatric decompensation  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Suicidal ideation  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Reproductive system and breast disorders         
Dyspareunia  1  1/101 (0.99%)  0/97 (0.00%)  0/47 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Bronchospasm  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/101 (0.00%)  0/97 (0.00%)  1/47 (2.13%)  0/20 (0.00%) 
Stevens-Johnson syndrome  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (0.00%) 
Vascular disorders         
Venous thrombosis limb  1  0/101 (0.00%)  1/97 (1.03%)  0/47 (0.00%)  0/20 (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   46/101 (45.54%)   56/97 (57.73%)   24/47 (51.06%)   8/20 (40.00%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia  1  1/101 (0.99%)  1/97 (1.03%)  3/47 (6.38%)  0/20 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper  1  7/101 (6.93%)  2/97 (2.06%)  0/47 (0.00%)  1/20 (5.00%) 
Diarrhoea  1  11/101 (10.89%)  11/97 (11.34%)  3/47 (6.38%)  2/20 (10.00%) 
Nausea  1  11/101 (10.89%)  7/97 (7.22%)  3/47 (6.38%)  2/20 (10.00%) 
General disorders         
Asthenia  1  3/101 (2.97%)  6/97 (6.19%)  2/47 (4.26%)  1/20 (5.00%) 
Fatigue  1  9/101 (8.91%)  9/97 (9.28%)  2/47 (4.26%)  1/20 (5.00%) 
Infections and infestations         
Bronchitis  1  10/101 (9.90%)  13/97 (13.40%)  5/47 (10.64%)  1/20 (5.00%) 
Gastroenteritis  1  2/101 (1.98%)  3/97 (3.09%)  4/47 (8.51%)  1/20 (5.00%) 
Herpes zoster  1  4/101 (3.96%)  1/97 (1.03%)  3/47 (6.38%)  1/20 (5.00%) 
Infection  1  5/101 (4.95%)  7/97 (7.22%)  2/47 (4.26%)  1/20 (5.00%) 
Nasopharyngitis  1  5/101 (4.95%)  6/97 (6.19%)  4/47 (8.51%)  2/20 (10.00%) 
Sinusitis  1  3/101 (2.97%)  4/97 (4.12%)  3/47 (6.38%)  1/20 (5.00%) 
Upper respiratory tract infection  1  12/101 (11.88%)  12/97 (12.37%)  8/47 (17.02%)  3/20 (15.00%) 
Urinary tract infection  1  2/101 (1.98%)  6/97 (6.19%)  0/47 (0.00%)  1/20 (5.00%) 
Investigations         
Alanine aminotransferase increased  1  1/101 (0.99%)  6/97 (6.19%)  2/47 (4.26%)  0/20 (0.00%) 
Blood cholesterol increased  1  5/101 (4.95%)  6/97 (6.19%)  2/47 (4.26%)  3/20 (15.00%) 
Gamma-glutamyltransferase increased  1  8/101 (7.92%)  16/97 (16.49%)  6/47 (12.77%)  1/20 (5.00%) 
Low density lipoprotein increased  1  4/101 (3.96%)  5/97 (5.15%)  2/47 (4.26%)  2/20 (10.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/101 (5.94%)  8/97 (8.25%)  0/47 (0.00%)  0/20 (0.00%) 
Back pain  1  5/101 (4.95%)  8/97 (8.25%)  0/47 (0.00%)  1/20 (5.00%) 
Pain in extremity  1  0/101 (0.00%)  6/97 (6.19%)  0/47 (0.00%)  1/20 (5.00%) 
Nervous system disorders         
Dizziness  1  4/101 (3.96%)  5/97 (5.15%)  1/47 (2.13%)  0/20 (0.00%) 
Headache  1  7/101 (6.93%)  11/97 (11.34%)  4/47 (8.51%)  3/20 (15.00%) 
Psychiatric disorders         
Depression  1  3/101 (2.97%)  15/97 (15.46%)  3/47 (6.38%)  1/20 (5.00%) 
Sleep disorder  1  3/101 (2.97%)  5/97 (5.15%)  0/47 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/101 (2.97%)  8/97 (8.25%)  2/47 (4.26%)  2/20 (10.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  4/101 (3.96%)  3/97 (3.09%)  3/47 (6.38%)  1/20 (5.00%) 
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: NCT01134939     History of Changes
Other Study ID Numbers: 1100.1536
First Submitted: June 1, 2010
First Posted: June 2, 2010
Results First Submitted: December 31, 2014
Results First Posted: January 21, 2015
Last Update Posted: January 21, 2015