Trial Outcomes & Findings for Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir (NCT NCT03374358)
NCT ID: NCT03374358
Last Updated: 2021-09-05
Results Overview
24 week value minus baseline value, liver fat % measured by proton magnetic resonance spectroscopy.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
Control (= no Intervention Arm).
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Control (= no Intervention Arm).
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Only those participants with data available at the specified time points were analyzed.
Baseline characteristics by cohort
| Measure |
Control (= no Intervention Arm).
n=24 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=19 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=24 Participants
|
49 years
n=19 Participants
|
49 years
n=43 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=24 Participants
|
4 Participants
n=19 Participants
|
9 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=24 Participants
|
15 Participants
n=19 Participants
|
34 Participants
n=43 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=43 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=24 Participants
|
18 Participants
n=19 Participants
|
40 Participants
n=43 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=43 Participants
|
|
Region of Enrollment
Finland
|
24 participants
n=24 Participants
|
19 participants
n=19 Participants
|
43 participants
n=43 Participants
|
|
Liver fat content
|
3.1 % hepatic fat fraction
n=23 Participants • Only those participants with data available at the specified time points were analyzed.
|
2.3 % hepatic fat fraction
n=19 Participants • Only those participants with data available at the specified time points were analyzed.
|
2.3 % hepatic fat fraction
n=42 Participants • Only those participants with data available at the specified time points were analyzed.
|
|
Subcutaneous adipose tissue volume
|
5377 mL
n=22 Participants • Only those participants with data available at the specified time points were analyzed.
|
3979 mL
n=18 Participants • Only those participants with data available at the specified time points were analyzed.
|
4468 mL
n=40 Participants • Only those participants with data available at the specified time points were analyzed.
|
|
Visceral adipose tissue volume
|
2053 mL
n=22 Participants • Only those participants with data available at the specified time points were analyzed.
|
1795 mL
n=18 Participants • Only those participants with data available at the specified time points were analyzed.
|
1906 mL
n=40 Participants • Only those participants with data available at the specified time points were analyzed.
|
|
Body weight
|
98.8 kg
n=23 Participants • Only those participants with data available at the specified time points were analyzed.
|
85.9 kg
n=19 Participants • Only those participants with data available at the specified time points were analyzed.
|
93.2 kg
n=42 Participants • Only those participants with data available at the specified time points were analyzed.
|
|
Total body fat
|
30.0 kg
n=23 Participants • Only those participants with data available at the specified data points were analyzed.
|
20.3 kg
n=19 Participants • Only those participants with data available at the specified data points were analyzed.
|
23.8 kg
n=42 Participants • Only those participants with data available at the specified data points were analyzed.
|
|
Liver stiffness
|
4.7 kPa
n=22 Participants • Only those participants with data available at the specified time points were analyzed.
|
4.1 kPa
n=19 Participants • Only those participants with data available at the specified time points were analyzed.
|
4.4 kPa
n=41 Participants • Only those participants with data available at the specified time points were analyzed.
|
|
Fasting plasma glucose
|
6.0 mmol/L
n=23 Participants • Only those participants with data available at the specified time points were analyzed.
|
5.5 mmol/L
n=19 Participants • Only those participants with data available at the specified time points were analyzed.
|
5.7 mmol/L
n=42 Participants • Only those participants with data available at the specified time points were analyzed.
|
|
Fasting serum LDL cholesterol
|
3.2 mmol/L
n=22 Participants • Only those participants with data available at the specific data points were analyzed.
|
3.2 mmol/L
n=19 Participants • Only those participants with data available at the specific data points were analyzed.
|
3.2 mmol/L
n=41 Participants • Only those participants with data available at the specific data points were analyzed.
|
|
Fasting serum HDL cholesterol
|
1.13 mmol/L
n=23 Participants • Only those participants with data available at the specified data points were analyzed.
|
1.30 mmol/L
n=19 Participants • Only those participants with data available at the specified data points were analyzed.
|
1.20 mmol/L
n=42 Participants • Only those participants with data available at the specified data points were analyzed.
|
|
Fasting serum triglyceride
|
1.3 mmol/L
n=23 Participants • Only those participants with data available at the specified data points were analyzed.
|
1.3 mmol/L
n=19 Participants • Only those participants with data available at the specified data points were analyzed.
|
1.3 mmol/L
n=42 Participants • Only those participants with data available at the specified data points were analyzed.
|
|
Serum high sensitivity CRP
|
2.4 mg/L
n=23 Participants • Only those participants with data available at the specified data points were analyzed.
|
1.0 mg/L
n=19 Participants • Only those participants with data available at the specified data points were analyzed.
|
1.3 mg/L
n=42 Participants • Only those participants with data available at the specified data points were analyzed.
|
|
Serum IL-6
|
2.2 pg/mL
n=22 Participants • Only those participants with data available at the specified data points were analyzed.
|
2.4 pg/mL
n=19 Participants • Only those participants with data available at the specified data points were analyzed.
|
2.2 pg/mL
n=41 Participants • Only those participants with data available at the specified data points were analyzed.
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified time points were analyzed.
24 week value minus baseline value, liver fat % measured by proton magnetic resonance spectroscopy.
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=21 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=18 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Liver Fat
|
0.3 % hepatic fat fraction
Interval -0.5 to 2.7
|
0.6 % hepatic fat fraction
Interval -0.3 to 1.6
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified time points were analyzed.
24 week value minus baseline value: change in subcutaneous (SAT) and visceral (VAT) adipose tissue volume (mL) measured by magnetic resonance imaging. Analysis included a series of T1-weighted trans-axial images from 8 cm above to 8 cm below the 4th and 5th lumbar intervertebral disc (16 slices, field of view 375 x 500 mm2, slice thickness 10 mm).
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=21 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=18 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Subcutaneous and Visceral Adipose Tissue Volume
Change in SAT (24 weeks - baseline)
|
-74 mL
Interval -627.0 to 202.0
|
242 mL
Interval 27.0 to 341.0
|
|
Change in Subcutaneous and Visceral Adipose Tissue Volume
Change in VAT (24 weeks - baseline)
|
100 mL
Interval -126.0 to 569.0
|
66 mL
Interval -149.0 to 299.0
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified time points were analyzed.
24 week value minus baseline value, change in body weight (kg) and total body fat (kg) measured by Bioelectrical Impedance Analysis.
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=21 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=18 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Body Weight and Total Body Fat
Change in body weight (24 weeks - baseline)
|
0.9 kg
Interval -1.8 to 4.1
|
2.0 kg
Interval 0.4 to 3.3
|
|
Change in Body Weight and Total Body Fat
Change in body fat (24 weeks - baseline)
|
-0.3 kg
Interval -1.7 to 1.5
|
1.5 kg
Interval 0.1 to 2.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified data points were analyzed.
24 week minus baseline value, change in liver stiffness (kPa) measured by transient elastography (Fibroscan ®).
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=19 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=18 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Liver Stiffness
|
-0.5 kPa
Interval -1.2 to 0.6
|
-0.2 kPa
Interval -1.6 to 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified data points were analyzed.
24 week value minus baseline value, change in fasting plasma glucose (mg/dL).
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=21 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=17 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
0.0 mg/dL
Interval -7.2 to 5.4
|
-1.8 mg/dL
Interval -10.8 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified data points were analyzed.
24 week value minus baseline value, change in fasting serum lipid profile: LDL and HDL cholesterol, triglyceride (all values in mmol/L)
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=20 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=18 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Fasting Serum Lipid Profile
Change in fasting serum LDL (24 weeks - baseline)
|
0.1 mmol/L
Interval -0.4 to 0.4
|
-0.5 mmol/L
Interval -1.0 to -0.1
|
|
Change in Fasting Serum Lipid Profile
Change in fasting serum HDL (24 weeks - baseline)
|
0.04 mmol/L
Interval -0.07 to 0.15
|
-0.07 mmol/L
Interval -0.16 to -0.01
|
|
Change in Fasting Serum Lipid Profile
Change in fasting serum triglycerides (24 weeks - baseline)
|
-0.05 mmol/L
Interval -0.28 to 0.2
|
-0.18 mmol/L
Interval -0.49 to 0.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified data points were analyzed.
24 week value minus baseline value, change in circulating metabolic and inflammatory biomarkers: high sensitivity C-reactive protein (hsCRP mg/L)
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=20 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=17 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Metabolic and Inflammatory Biomarkers: hsCRP
|
0.66 mg/L
Interval -0.07 to 1.45
|
-0.06 mg/L
Interval -0.59 to 0.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 24 weeksPopulation: Only those participants with data available at the specified data points were analyzed.
24 week value minus baseline value, change in circulating metabolic and inflammatory biomarkers: interleukin 6 (IL-6 pg/mL)
Outcome measures
| Measure |
Control (= no Intervention Arm).
n=20 Participants
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=17 Participants
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Change in Metabolic and Inflammatory Biomarkers: IL-6
|
0.83 pg/mL
Interval -0.09 to 1.2
|
0.00 pg/mL
Interval -0.87 to 0.64
|
Adverse Events
Control (= no Intervention Arm).
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Raltegravir Arm.
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control (= no Intervention Arm).
n=24 participants at risk
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=19 participants at risk
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Gastrointestinal disorders
Acute pancreatitis
|
4.2%
1/24 • Number of events 1 • 6 months.
|
0.00%
0/19 • 6 months.
|
Other adverse events
| Measure |
Control (= no Intervention Arm).
n=24 participants at risk
Study subjects will continue their current antiretroviral regimens, which include a protease inhibitor or efavirenz plus two nucleoside analog reverse-transcriptase inhibitors (NRTIs).
|
Raltegravir Arm.
n=19 participants at risk
Study subjects will switch their protease inhibitor or efavirenz to once daily raltegravir plus continue current nucleoside analog reverse-transcriptase inhibitors (NRTIs).
Raltegravir: The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
|
|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
8/24 • 6 months.
|
47.4%
9/19 • 6 months.
|
|
Gastrointestinal disorders
Gastrointestinal (diarrhoea, nausea)
|
29.2%
7/24 • 6 months.
|
47.4%
9/19 • 6 months.
|
|
Psychiatric disorders
Sleeping difficulties
|
54.2%
13/24 • 6 months.
|
52.6%
10/19 • 6 months.
|
|
Psychiatric disorders
Nervousness
|
37.5%
9/24 • 6 months.
|
36.8%
7/19 • 6 months.
|
|
Nervous system disorders
Dizzyness
|
33.3%
8/24 • 6 months.
|
26.3%
5/19 • 6 months.
|
|
Psychiatric disorders
Depressed mood
|
29.2%
7/24 • 6 months.
|
26.3%
5/19 • 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place