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Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

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ClinicalTrials.gov Identifier: NCT00757783
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : September 10, 2010
Last Update Posted : December 30, 2015
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Interventions Drug: ritonavir
Drug: darunavir
Drug: emtricitabine [FTC]/tenofovir [TDF]
Drug: atazanavir
Enrollment 68
Recruitment Details  
Pre-assignment Details A total of 68 participants were enrolled in the study, and out of which 65 were treated.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks. atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Period Title: Overall Study
Started 34 31
Completed 29 25
Not Completed 5 6
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             1             1
Protocol Violation             1             0
Withdrawal by Subject             2             1
Other             1             2
Arm/Group Title Darunavir Atazanavir Total
Hide Arm/Group Description Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks. atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 34 31 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 31 participants 65 participants
35.9  (10.35) 36.9  (11.66) 36.4  (10.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 31 participants 65 participants
Female
5
  14.7%
4
  12.9%
9
  13.8%
Male
29
  85.3%
27
  87.1%
56
  86.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
US Number Analyzed 34 participants 31 participants 65 participants
34 31 65
1.Primary Outcome
Title Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Hide Description Observed values.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: milligram per deciliters (mg/dL)
Baseline (n=28,27) 113.7  (57.40) 114.2  (84.05)
Change at Week 12 (n=27,27) 22.0  (62.72) 8.1  (81.15)
2.Secondary Outcome
Title Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Hide Description Observed Values
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n= 28, 27) 141.8  (28.30) 165.1  (29.93)
Change at Week 12 (n= 27, 27) 20.3  (30.48) 4.6  (26.66)
Change at Week 48 (n= 26, 22) 22.3  (30.74) 11.8  (31.93)
3.Secondary Outcome
Title Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Hide Description Observed Values
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=28, 27) 84.6  (21.93) 100.2  (23.89)
Change at Week 12 (n=27, 27) 13.6  (25.12) 9.6  (20.78)
Change at Week 48 (n=26, 22) 14.7  (25.91) 13.9  (27.14)
4.Secondary Outcome
Title Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Hide Description Observed Values
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=28,27) 37.9  (13.36) 45.0  (13.56)
Change at Week 12 (n=27,27) 6.6  (11.58) 2.2  (8.74)
Change at Week 48 (n=26,22) 6.0  (7.43) 3.7  (9.89)
5.Secondary Outcome
Title Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Hide Description Observed Values
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: grams per liters (g/L)
Baseline (n=28,27) 1.1  (0.26) 1.3  (0.22)
Change at Week 12 (n=27,27) 0.1  (0.21) -0.007  (0.18)
Change at Week 48 (n=26,22) 0.1  (0.16) 0.0  (0.19)
6.Secondary Outcome
Title Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Hide Description Observed Values
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (n=28,27) 0.7  (0.19) 0.8  (0.19)
Change at Week 12 (n=27,27) -0.004  (0.20) -0.05  (0.16)
Change at Week 48 (n=26,22) 0.0  (0.21) 0.0  (0.17)
7.Secondary Outcome
Title Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Hide Description Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (n=28,27) 4.1  (1.14) 3.9  (1.02)
Change at Week 12 (n=27,27) -0.1  (0.91) -0.1  (0.67)
Change at Week 48 (n=26,22) 0.1  (1.06) -0.1  (0.75)
8.Secondary Outcome
Title Change From Baseline in Glucose at Week 12 and 48.
Hide Description Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 33 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=33,30) 88.5  (12.37) 89.7  (10.84)
Change at Week 12 (n=30,29) 1.5  (12.52) 5.8  (14.55)
Change at Week 48 (n=28,24) 2.8  (9.10) 6.4  (22.07)
9.Secondary Outcome
Title Change From Baseline in Insulin at Week 12 and 48.
Hide Description Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 33 30
Mean (Standard Deviation)
Unit of Measure: IU/mL
Baseline (n=33,30) 5.96  (5.566) 8.59  (14.278)
Change at Week 12 (n=30,29) -1.07  (4.970) 0.70  (18.790)
Change at Week 48 (n=28,24) 0.95  (6.006) -2.88  (16.731)
10.Secondary Outcome
Title Change From Baseline in Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) at Week 12 and 48.
Hide Description Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: HOMA-IR score
Baseline (n=27,22) 1.624  (1.6962) 2.943  (6.0204)
Change at Week 12 (n=20,21) -0.483  (2.0243) 0.105  (7.5121)
Change at Week 48 (n=19,14) 0.035  (2.2580) -1.236  (8.0114)
11.Secondary Outcome
Title Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Hide Description Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.
Time Frame Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 34 31
Measure Type: Number
Unit of Measure: number of participants
Week12: HIV-1 RNA Less Than (<) 50 copies/mL 13 19
Week 12: HIV-1 RNA < 400 copies/mL 28 29
Week 48: HIV-1 RNA < 50 copies/mL 25 22
Week 48: HIV-1 RNA < 400 copies/mL 28 24
12.Secondary Outcome
Title Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Hide Description Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.
Time Frame Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 34 31
Measure Type: Number
Unit of Measure: number of participants
Week 12: HIV-1 RNA Less Than (<) 50 copies/mL 13 19
Week 12: HIV-1 RNA < 400 copies/mL 28 28
Week 48: HIV-1 RNA < 50 copies/mL 25 22
Week 48: HIV-1 RNA < 400 copies/mL 28 24
13.Secondary Outcome
Title Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
Hide Description the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 34 31
Mean (Standard Deviation)
Unit of Measure: Log10 HIV RNA
Baseline (n=34,31) 5.016  (0.7846) 4.562  (0.6535)
Change at Week 12 (n=32,30) -2.955  (0.8081) -2.605  (0.7035)
Change at Week 48 (n=29,24) -3.269  (0.8304) -2.902  (0.6620)
14.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Hide Description Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 34 31
Mean (Standard Deviation)
Unit of Measure: cells/micro L
Baseline (n=34,31) 268.3  (144.17) 326.7  (174.13)
Change at Week 12 (n=32,29) 111.1  (97.25) 68.3  (134.60)
Change at Week 48 (n=29,25) 217.4  (116.76) 205.3  (153.54)
15.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Hide Description Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 34 31
Mean (Standard Deviation)
Unit of Measure: cells/uL
Baseline (n=34,31) 268.3  (144.17) 326.7  (174.13)
Change at Week 12 (n=34,31) 103.4  (101.01) 74.6  (132.49)
Change at Week 48 (n=34,31) 194.9  (139.68) 187.7  (146.28)
16.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Hide Description Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.
Time Frame Baseline, Week 12 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description:
Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Overall Number of Participants Analyzed 34 31
Mean (Standard Deviation)
Unit of Measure: percentage of CD4 cells
Baseline (n=34,31) 18.6  (9.89) 21.4  (9.25)
Change at Week 12 (n=32,30) 5.9  (6.02) 4.5  (5.25)
Change at Week 48 (n=29,25) 9.6  (7.24) 8.5  (5.51)
Time Frame Week 48
Adverse Event Reporting Description Safety population included all participants who received at least one dose of study drug.
 
Arm/Group Title Darunavir Atazanavir
Hide Arm/Group Description Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks. atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
All-Cause Mortality
Darunavir Atazanavir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Darunavir Atazanavir
Affected / at Risk (%) Affected / at Risk (%)
Total   5/31 (16.13%)   5/29 (17.24%) 
Cardiac disorders     
Mitral Valve Incompetence * 1  0/31 (0.00%)  1/29 (3.45%) 
Gastrointestinal disorders     
Pancreatitis * 1  1/31 (3.23%)  0/29 (0.00%) 
General disorders     
Chest Pain * 1  0/31 (0.00%)  1/29 (3.45%) 
Immune system disorders     
Immune Reconstitution Syndrome * 1  1/31 (3.23%)  0/29 (0.00%) 
Infections and infestations     
Bacteraemia * 1  0/31 (0.00%)  1/29 (3.45%) 
Pneumonia * 1  0/31 (0.00%)  1/29 (3.45%) 
Injury, poisoning and procedural complications     
Fracture of Penis * 1  0/31 (0.00%)  1/29 (3.45%) 
Muscle Strain * 1  1/31 (3.23%)  0/29 (0.00%) 
Pneumonitis Chemical * 1  0/31 (0.00%)  1/29 (3.45%) 
Investigations     
Blood Glucose Increased * 1  1/31 (3.23%)  0/29 (0.00%) 
Metabolism and nutrition disorders     
Diabetes Mellitus * 1  1/31 (3.23%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease * 1  1/31 (3.23%)  0/29 (0.00%) 
Respiratory Distress * 1  1/31 (3.23%)  0/29 (0.00%) 
Skin and subcutaneous tissue disorders     
Purpura * 1  0/31 (0.00%)  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Darunavir Atazanavir
Affected / at Risk (%) Affected / at Risk (%)
Total   28/31 (90.32%)   25/29 (86.21%) 
Blood and lymphatic system disorders     
Neutropenia * 1  2/31 (6.45%)  2/29 (6.90%) 
Eye disorders     
Ocular Icterus * 1  0/31 (0.00%)  5/29 (17.24%) 
Gastrointestinal disorders     
Abdominal Distension * 1  3/31 (9.68%)  2/29 (6.90%) 
Abdominal Pain * 1  1/31 (3.23%)  2/29 (6.90%) 
Diarrhoea * 1  10/31 (32.26%)  5/29 (17.24%) 
Dyspepsia * 1  1/31 (3.23%)  2/29 (6.90%) 
Flatulence * 1  2/31 (6.45%)  2/29 (6.90%) 
Nausea * 1  8/31 (25.81%)  2/29 (6.90%) 
General disorders     
Fatigue * 1  4/31 (12.90%)  3/29 (10.34%) 
Pain * 1  2/31 (6.45%)  0/29 (0.00%) 
Pyrexia * 1  4/31 (12.90%)  1/29 (3.45%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  0/31 (0.00%)  4/29 (13.79%) 
Jaundice * 1  0/31 (0.00%)  3/29 (10.34%) 
Immune system disorders     
Immune Reconstitution Syndrome * 1  3/31 (9.68%)  0/29 (0.00%) 
Seasonal Allergy * 1  0/31 (0.00%)  2/29 (6.90%) 
Infections and infestations     
Folliculitis * 1  0/31 (0.00%)  2/29 (6.90%) 
Furuncle * 1  0/31 (0.00%)  2/29 (6.90%) 
Influenza * 1  2/31 (6.45%)  0/29 (0.00%) 
Oral Herpes * 1  1/31 (3.23%)  2/29 (6.90%) 
Tinea Pedis * 1  2/31 (6.45%)  0/29 (0.00%) 
Upper Respiratory Tract Infection * 1  2/31 (6.45%)  2/29 (6.90%) 
Urinary Tract Infection * 1  1/31 (3.23%)  2/29 (6.90%) 
Investigations     
Blood Bilirubin Increased * 1  0/31 (0.00%)  10/29 (34.48%) 
Blood Cholesterol Increased * 1  1/31 (3.23%)  2/29 (6.90%) 
Low Density Lipoprotein Increased * 1  4/31 (12.90%)  3/29 (10.34%) 
Neutrophil Count Decreased * 1  0/31 (0.00%)  2/29 (6.90%) 
Weight Decreased * 1  2/31 (6.45%)  0/29 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  2/31 (6.45%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in Extremity * 1  1/31 (3.23%)  3/29 (10.34%) 
Nervous system disorders     
Dizziness * 1  1/31 (3.23%)  2/29 (6.90%) 
Headache * 1  2/31 (6.45%)  2/29 (6.90%) 
Psychiatric disorders     
Depression * 1  1/31 (3.23%)  6/29 (20.69%) 
Insomnia * 1  1/31 (3.23%)  3/29 (10.34%) 
Renal and urinary disorders     
Pollakiuria * 1  0/31 (0.00%)  2/29 (6.90%) 
Reproductive system and breast disorders     
Penile Discharge * 1  2/31 (6.45%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  5/31 (16.13%)  0/29 (0.00%) 
Sinus Congestion * 1  2/31 (6.45%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders     
Acne * 1  2/31 (6.45%)  0/29 (0.00%) 
Rash * 1  2/31 (6.45%)  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
65 subjects were enrolled/treated in the main study. 3 subjects were enrolled, randomized, not treated and excluded from analyses (n=68). An additional 18 subjects were enrolled in a substudy extension and excluded from the main analyses.
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.
If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.
Results Point of Contact
Name/Title: Vice President, Tibotec Therapeutics Clinical Affairs
Organization: Johnson & Johnson Pharmaceutical Research & Development
Phone: 877-732-2488
Responsible Party: Tibotec, Inc
ClinicalTrials.gov Identifier: NCT00757783     History of Changes
Other Study ID Numbers: CR015439
TMC114HIV4023 ( Other Identifier: Tibotec, Inc. )
First Submitted: September 19, 2008
First Posted: September 23, 2008
Results First Submitted: August 12, 2010
Results First Posted: September 10, 2010
Last Update Posted: December 30, 2015