Trial Outcomes & Findings for Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r (NCT NCT00756730)
NCT ID: NCT00756730
Last Updated: 2017-08-21
Results Overview
A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
baseline, 24 weeks
Results posted on
2017-08-21
Participant Flow
Participant milestones
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Overall Study
discontinued due to rash prior to week 4
|
0
|
1
|
|
Overall Study
persistent low-level viremmia
|
0
|
1
|
Baseline Characteristics
Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r
Baseline characteristics by cohort
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=24 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
48 years
n=5 Participants
|
46 years
n=7 Participants
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
CD4 Count
|
584 cells/mm3
n=5 Participants
|
554 cells/mm3
n=7 Participants
|
569 cells/mm3
n=5 Participants
|
|
Viral Load
|
NA copies/mL
n=5 Participants
|
NA copies/mL
n=7 Participants
|
0 copies/mL
n=5 Participants
|
|
Baseline antiretroviral medications - Protease inhibitors
Lopinavir/ritonavir (LPV/r)
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Baseline antiretroviral medications - Protease inhibitors
fosamprenavir/ritonavir (FPV/r)
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Baseline medications - Nucleoside analogs
viread (TDF)/emtriva (FTC)
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Baseline medications - Nucleoside analogs
ziagen (ABC)/Epivir (3TC)
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Baseline medications - Nucleoside analogs
other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Lipid Lowering Medications
statin
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Lipid Lowering Medications
fibrate
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Lipid Lowering Medications
fish oil
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Lipid Lowering Medications
niacin
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Lipid Lowering Medications
none
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 24 weeksPopulation: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.
A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.
Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=22 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.
|
80 percentage of patients
|
73 percentage of patients
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.
Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=22 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL
|
48 percentage of participants
|
55 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.
Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=22 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
The Change in Fasting Triglyceride Level From Baseline to Week 24
|
-126 mg/dL
Interval -312.0 to 133.0
|
-88 mg/dL
Interval -469.0 to 90.0
|
SECONDARY outcome
Timeframe: Week 4, 12 & 24Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=24 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
Week 4
|
100 percentage of participants
|
100 percentage of participants
|
|
Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
Week 12
|
100 percentage of participants
|
100 percentage of participants
|
|
Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
Week 24
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to Week 24Population: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.
Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=22 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Difference in CD4 From Baseline to Week 24
|
10.75 cells/mm^3
Standard Error 17.67
|
14.28 cells/mm^3
Standard Error 19.77
|
SECONDARY outcome
Timeframe: Week 24Population: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.
Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=22 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Total Cholesterol in the Two Study Groups at 24 Weeks
|
195 mg/dL
Interval 110.0 to 311.0
|
195 mg/dL
Interval 132.0 to 304.0
|
SECONDARY outcome
Timeframe: week 24Population: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.
Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=22 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
LDL Cholesterol at Week 24
|
116 mg/dL
Interval 55.0 to 180.0
|
111 mg/dL
Interval 46.0 to 204.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.
Outcome measures
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=22 Participants
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
HDL Cholesterol at Week 24
|
38 mg/dL
Interval 22.0 to 54.0
|
40 mg/dL
Interval 26.0 to 55.0
|
Adverse Events
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 participants at risk
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=24 participants at risk
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Gastrointestinal disorders
possible bowel obstruction
|
0.00%
0/25 • Baseline to 24 weeks
|
4.2%
1/24 • Number of events 1 • Baseline to 24 weeks
|
|
Psychiatric disorders
alcohol withdrawal/suicidal Ideation
|
0.00%
0/25 • Baseline to 24 weeks
|
4.2%
1/24 • Number of events 1 • Baseline to 24 weeks
|
|
Renal and urinary disorders
urosepsis
|
4.0%
1/25 • Number of events 1 • Baseline to 24 weeks
|
0.00%
0/24 • Baseline to 24 weeks
|
Other adverse events
| Measure |
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD
n=25 participants at risk
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
|
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
n=24 participants at risk
Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection (URI)
|
20.0%
5/25 • Number of events 5 • Baseline to 24 weeks
|
20.8%
5/24 • Number of events 5 • Baseline to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
8.0%
2/25 • Number of events 2 • Baseline to 24 weeks
|
4.2%
1/24 • Number of events 1 • Baseline to 24 weeks
|
|
Vascular disorders
Erectile Dysfunction
|
0.00%
0/25 • Baseline to 24 weeks
|
8.3%
2/24 • Number of events 2 • Baseline to 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place