Trial Outcomes & Findings for 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 (NCT NCT00757783)
NCT ID: NCT00757783
Last Updated: 2015-12-30
Results Overview
Observed values.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2015-12-30
Participant Flow
A total of 68 participants were enrolled in the study, and out of which 65 were treated.
Participant milestones
| Measure |
Darunavir
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
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 Study
STARTED
|
34
|
31
|
|
Overall Study
COMPLETED
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Darunavir
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
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 Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Darunavir
n=34 Participants
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
n=31 Participants
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
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 11.66 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
US
|
34 participants
n=5 Participants
|
31 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: 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.
Observed values.
Outcome measures
| Measure |
Darunavir
n=28 Participants
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
n=27 Participants
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
|
|---|---|---|
|
Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Baseline (n=28,27)
|
113.7 milligram per deciliters (mg/dL)
Standard Deviation 57.40
|
114.2 milligram per deciliters (mg/dL)
Standard Deviation 84.05
|
|
Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Change at Week 12 (n=27,27)
|
22.0 milligram per deciliters (mg/dL)
Standard Deviation 62.72
|
8.1 milligram per deciliters (mg/dL)
Standard Deviation 81.15
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Observed Values
Outcome measures
| Measure |
Darunavir
n=28 Participants
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
n=27 Participants
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
|
|---|---|---|
|
Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Baseline (n= 28, 27)
|
141.8 mg/dL
Standard Deviation 28.30
|
165.1 mg/dL
Standard Deviation 29.93
|
|
Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Change at Week 12 (n= 27, 27)
|
20.3 mg/dL
Standard Deviation 30.48
|
4.6 mg/dL
Standard Deviation 26.66
|
|
Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Change at Week 48 (n= 26, 22)
|
22.3 mg/dL
Standard Deviation 30.74
|
11.8 mg/dL
Standard Deviation 31.93
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Observed Values
Outcome measures
| Measure |
Darunavir
n=28 Participants
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
n=27 Participants
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
|
|---|---|---|
|
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Baseline (n=28, 27)
|
84.6 mg/dL
Standard Deviation 21.93
|
100.2 mg/dL
Standard Deviation 23.89
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Change at Week 12 (n=27, 27)
|
13.6 mg/dL
Standard Deviation 25.12
|
9.6 mg/dL
Standard Deviation 20.78
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Change at Week 48 (n=26, 22)
|
14.7 mg/dL
Standard Deviation 25.91
|
13.9 mg/dL
Standard Deviation 27.14
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Observed Values
Outcome measures
| Measure |
Darunavir
n=28 Participants
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
n=27 Participants
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
|
|---|---|---|
|
Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Baseline (n=28,27)
|
37.9 mg/dL
Standard Deviation 13.36
|
45.0 mg/dL
Standard Deviation 13.56
|
|
Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Change at Week 12 (n=27,27)
|
6.6 mg/dL
Standard Deviation 11.58
|
2.2 mg/dL
Standard Deviation 8.74
|
|
Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Change at Week 48 (n=26,22)
|
6.0 mg/dL
Standard Deviation 7.43
|
3.7 mg/dL
Standard Deviation 9.89
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Observed Values
Outcome measures
| Measure |
Darunavir
n=28 Participants
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
n=27 Participants
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
|
|---|---|---|
|
Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Baseline (n=28,27)
|
1.1 grams per liters (g/L)
Standard Deviation 0.26
|
1.3 grams per liters (g/L)
Standard Deviation 0.22
|
|
Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Change at Week 12 (n=27,27)
|
0.1 grams per liters (g/L)
Standard Deviation 0.21
|
-0.007 grams per liters (g/L)
Standard Deviation 0.18
|
|
Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Change at Week 48 (n=26,22)
|
0.1 grams per liters (g/L)
Standard Deviation 0.16
|
0.0 grams per liters (g/L)
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Observed Values
Outcome measures
| Measure |
Darunavir
n=28 Participants
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
n=27 Participants
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
|
|---|---|---|
|
Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Baseline (n=28,27)
|
0.7 g/L
Standard Deviation 0.19
|
0.8 g/L
Standard Deviation 0.19
|
|
Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Change at Week 12 (n=27,27)
|
-0.004 g/L
Standard Deviation 0.20
|
-0.05 g/L
Standard Deviation 0.16
|
|
Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Change at Week 48 (n=26,22)
|
0.0 g/L
Standard Deviation 0.21
|
0.0 g/L
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
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.
Outcome measures
| Measure |
Darunavir
n=28 Participants
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
n=27 Participants
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
|
|---|---|---|
|
Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Baseline (n=28,27)
|
4.1 ratio
Standard Deviation 1.14
|
3.9 ratio
Standard Deviation 1.02
|
|
Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Change at Week 12 (n=27,27)
|
-0.1 ratio
Standard Deviation 0.91
|
-0.1 ratio
Standard Deviation 0.67
|
|
Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Change at Week 48 (n=26,22)
|
0.1 ratio
Standard Deviation 1.06
|
-0.1 ratio
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.
Outcome measures
| Measure |
Darunavir
n=33 Participants
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
n=30 Participants
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
|
|---|---|---|
|
Change From Baseline in Glucose at Week 12 and 48.
Baseline (n=33,30)
|
88.5 mg/dL
Standard Deviation 12.37
|
89.7 mg/dL
Standard Deviation 10.84
|
|
Change From Baseline in Glucose at Week 12 and 48.
Change at Week 12 (n=30,29)
|
1.5 mg/dL
Standard Deviation 12.52
|
5.8 mg/dL
Standard Deviation 14.55
|
|
Change From Baseline in Glucose at Week 12 and 48.
Change at Week 48 (n=28,24)
|
2.8 mg/dL
Standard Deviation 9.10
|
6.4 mg/dL
Standard Deviation 22.07
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.
Outcome measures
| Measure |
Darunavir
n=33 Participants
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
n=30 Participants
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
|
|---|---|---|
|
Change From Baseline in Insulin at Week 12 and 48.
Baseline (n=33,30)
|
5.96 IU/mL
Standard Deviation 5.566
|
8.59 IU/mL
Standard Deviation 14.278
|
|
Change From Baseline in Insulin at Week 12 and 48.
Change at Week 12 (n=30,29)
|
-1.07 IU/mL
Standard Deviation 4.970
|
0.70 IU/mL
Standard Deviation 18.790
|
|
Change From Baseline in Insulin at Week 12 and 48.
Change at Week 48 (n=28,24)
|
0.95 IU/mL
Standard Deviation 6.006
|
-2.88 IU/mL
Standard Deviation 16.731
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
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).
Outcome measures
| Measure |
Darunavir
n=27 Participants
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
n=22 Participants
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
|
|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
Baseline (n=27,22)
|
1.624 HOMA-IR score
Standard Deviation 1.6962
|
2.943 HOMA-IR score
Standard Deviation 6.0204
|
|
Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
Change at Week 12 (n=20,21)
|
-0.483 HOMA-IR score
Standard Deviation 2.0243
|
0.105 HOMA-IR score
Standard Deviation 7.5121
|
|
Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
Change at Week 48 (n=19,14)
|
0.035 HOMA-IR score
Standard Deviation 2.2580
|
-1.236 HOMA-IR score
Standard Deviation 8.0114
|
SECONDARY outcome
Timeframe: Week 12 and 48Population: 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.
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.
Outcome measures
| Measure |
Darunavir
n=34 Participants
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
n=31 Participants
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
|
|---|---|---|
|
Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Week12: HIV-1 RNA Less Than (<) 50 copies/mL
|
13 number of participants
|
19 number of participants
|
|
Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Week 12: HIV-1 RNA < 400 copies/mL
|
28 number of participants
|
29 number of participants
|
|
Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Week 48: HIV-1 RNA < 50 copies/mL
|
25 number of participants
|
22 number of participants
|
|
Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Week 48: HIV-1 RNA < 400 copies/mL
|
28 number of participants
|
24 number of participants
|
SECONDARY outcome
Timeframe: Week 12 and 48Population: 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.
Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.
Outcome measures
| Measure |
Darunavir
n=34 Participants
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
n=31 Participants
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
|
|---|---|---|
|
Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Week 12: HIV-1 RNA Less Than (<) 50 copies/mL
|
13 number of participants
|
19 number of participants
|
|
Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Week 12: HIV-1 RNA < 400 copies/mL
|
28 number of participants
|
28 number of participants
|
|
Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Week 48: HIV-1 RNA < 50 copies/mL
|
25 number of participants
|
22 number of participants
|
|
Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Week 48: HIV-1 RNA < 400 copies/mL
|
28 number of participants
|
24 number of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.
Outcome measures
| Measure |
Darunavir
n=34 Participants
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
n=31 Participants
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
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
Baseline (n=34,31)
|
5.016 Log10 HIV RNA
Standard Deviation 0.7846
|
4.562 Log10 HIV RNA
Standard Deviation 0.6535
|
|
Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
Change at Week 12 (n=32,30)
|
-2.955 Log10 HIV RNA
Standard Deviation 0.8081
|
-2.605 Log10 HIV RNA
Standard Deviation 0.7035
|
|
Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
Change at Week 48 (n=29,24)
|
-3.269 Log10 HIV RNA
Standard Deviation 0.8304
|
-2.902 Log10 HIV RNA
Standard Deviation 0.6620
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.
Outcome measures
| Measure |
Darunavir
n=34 Participants
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
n=31 Participants
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
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Baseline (n=34,31)
|
268.3 cells/micro L
Standard Deviation 144.17
|
326.7 cells/micro L
Standard Deviation 174.13
|
|
Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Change at Week 12 (n=32,29)
|
111.1 cells/micro L
Standard Deviation 97.25
|
68.3 cells/micro L
Standard Deviation 134.60
|
|
Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Change at Week 48 (n=29,25)
|
217.4 cells/micro L
Standard Deviation 116.76
|
205.3 cells/micro L
Standard Deviation 153.54
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
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.
Outcome measures
| Measure |
Darunavir
n=34 Participants
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
n=31 Participants
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
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Baseline (n=34,31)
|
268.3 cells/uL
Standard Deviation 144.17
|
326.7 cells/uL
Standard Deviation 174.13
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Change at Week 12 (n=34,31)
|
103.4 cells/uL
Standard Deviation 101.01
|
74.6 cells/uL
Standard Deviation 132.49
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Change at Week 48 (n=34,31)
|
194.9 cells/uL
Standard Deviation 139.68
|
187.7 cells/uL
Standard Deviation 146.28
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 48Population: 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.
Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.
Outcome measures
| Measure |
Darunavir
n=34 Participants
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
n=31 Participants
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
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Baseline (n=34,31)
|
18.6 percentage of CD4 cells
Standard Deviation 9.89
|
21.4 percentage of CD4 cells
Standard Deviation 9.25
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Change at Week 12 (n=32,30)
|
5.9 percentage of CD4 cells
Standard Deviation 6.02
|
4.5 percentage of CD4 cells
Standard Deviation 5.25
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Change at Week 48 (n=29,25)
|
9.6 percentage of CD4 cells
Standard Deviation 7.24
|
8.5 percentage of CD4 cells
Standard Deviation 5.51
|
Adverse Events
Darunavir
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Atazanavir
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Darunavir
n=31 participants at risk
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
n=29 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Chest Pain
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Immune system disorders
Immune Reconstitution Syndrome
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture of Penis
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pneumonitis Chemical
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Glucose Increased
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Darunavir
n=31 participants at risk
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
n=29 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Penile Discharge
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
5/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular Icterus
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
17.2%
5/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.7%
3/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.3%
10/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
17.2%
5/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.8%
8/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
12.9%
4/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
12.9%
4/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
3.4%
1/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
13.8%
4/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Immune system disorders
Immune Reconstitution Syndrome
|
9.7%
3/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral Herpes
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea Pedis
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
34.5%
10/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Blood Cholesterol Increased
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Low Density Lipoprotein Increased
|
12.9%
4/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Weight Decreased
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
10.3%
3/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
6.9%
2/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
20.7%
6/29 • Week 48
Safety population included all participants who received at least one dose of study drug.
|
Additional Information
Vice President, Tibotec Therapeutics Clinical Affairs
Johnson & Johnson Pharmaceutical Research & Development
Phone: 877-732-2488
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER