Trial Outcomes & Findings for Eplerenone in HIV Associated Abdominal Fat Accumulation (NCT NCT01405456)
NCT ID: NCT01405456
Last Updated: 2018-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
6 months
Results posted on
2018-06-15
Participant Flow
Participant milestones
| Measure |
Eplerenone and Lifestyle
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Eplerenone and Lifestyle
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Endpoint could not be obtained. Subject was unable to complete the procedure.
Baseline characteristics by cohort
| Measure |
Eplerenone and Lifestyle
n=25 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=21 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 6 • n=25 Participants
|
52 years
STANDARD_DEVIATION 6 • n=21 Participants
|
51 years
STANDARD_DEVIATION 6 • n=46 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=25 Participants
|
6 Participants
n=21 Participants
|
16 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=25 Participants
|
15 Participants
n=21 Participants
|
30 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=25 Participants
|
11 Participants
n=21 Participants
|
20 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=25 Participants
|
9 Participants
n=21 Participants
|
24 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=25 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=46 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants
|
21 Participants
n=21 Participants
|
46 Participants
n=46 Participants
|
|
Insulin Stimulated Glucose Uptake
|
7.26 mg/min per μIU/ml
n=24 Participants • Endpoint could not be obtained. Subject was unable to complete the procedure.
|
7.52 mg/min per μIU/ml
n=21 Participants • Endpoint could not be obtained. Subject was unable to complete the procedure.
|
7.44 mg/min per μIU/ml
n=45 Participants • Endpoint could not be obtained. Subject was unable to complete the procedure.
|
|
Visceral Adipose Tissue
|
215 cm^2
n=23 Participants • Endpoint could not be obtained. Subjects could could not complete the procedure.
|
241 cm^2
n=21 Participants • Endpoint could not be obtained. Subjects could could not complete the procedure.
|
230 cm^2
n=44 Participants • Endpoint could not be obtained. Subjects could could not complete the procedure.
|
|
Liver Fat
|
5 percentage of intrahepatic lipid
n=22 Participants • Endpoint could not be obtained. Subjects could not complete the procedure.
|
5 percentage of intrahepatic lipid
n=21 Participants • Endpoint could not be obtained. Subjects could not complete the procedure.
|
5 percentage of intrahepatic lipid
n=43 Participants • Endpoint could not be obtained. Subjects could not complete the procedure.
|
|
Intramyocellular Lipid
|
0.5 percentage of intramyocellular lipid
n=24 Participants • Endpoint could not be obtained. Subjects could not complete the procedure.
|
0.3 percentage of intramyocellular lipid
n=21 Participants • Endpoint could not be obtained. Subjects could not complete the procedure.
|
0.4 percentage of intramyocellular lipid
n=45 Participants • Endpoint could not be obtained. Subjects could not complete the procedure.
|
|
Flow Mediated Vasodilation
|
13.0 percentage of maximum change
n=24 Participants • Endpoint could not be obtained. Studies were of poor quality and data could not be analyzed.
|
13.4 percentage of maximum change
n=19 Participants • Endpoint could not be obtained. Studies were of poor quality and data could not be analyzed.
|
13.0 percentage of maximum change
n=43 Participants • Endpoint could not be obtained. Studies were of poor quality and data could not be analyzed.
|
|
Potassium
|
4.1 mEq/L
STANDARD_DEVIATION 0.2 • n=25 Participants
|
4.0 mEq/L
STANDARD_DEVIATION 0.2 • n=21 Participants
|
4.1 mEq/L
STANDARD_DEVIATION 0.2 • n=46 Participants
|
|
Hemoglobin A1c
|
5.7 percentage
n=25 Participants
|
5.8 percentage
n=21 Participants
|
5.7 percentage
n=46 Participants
|
|
C-reactive Protein
|
3.3 mg/L
n=24 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
3.7 mg/L
n=21 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
3.4 mg/L
n=45 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
|
Plasminogen Activator Inhibitor 1
|
36.7 ng/mL
STANDARD_DEVIATION 18.3 • n=24 Participants • Endpoint could not be obtained. Sufficient sample was not obtained.
|
37.0 ng/mL
STANDARD_DEVIATION 18.7 • n=21 Participants • Endpoint could not be obtained. Sufficient sample was not obtained.
|
36.9 ng/mL
STANDARD_DEVIATION 18.3 • n=45 Participants • Endpoint could not be obtained. Sufficient sample was not obtained.
|
|
Adiponectin
|
4016 pg/mL
n=24 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
4673 pg/mL
n=21 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
4527 pg/mL
n=45 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
|
Markers of Systemic Inflammation
|
10.2 pg/mL
n=24 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
7.9 pg/mL
n=21 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
9.1 pg/mL
n=45 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
|
Markers of Immune Activation
|
205 pg/mL
STANDARD_DEVIATION 78 • n=24 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
191 pg/mL
STANDARD_DEVIATION 51 • n=21 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
198 pg/mL
STANDARD_DEVIATION 66 • n=45 Participants • Endpoint could not be evaluated. Sufficient sample was not obtained.
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=21 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=20 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Insulin Stimulated Glucose Uptake
|
7.70 mg/min per μIU/ml
Interval 5.01 to 8.36
|
8.58 mg/min per μIU/ml
Interval 5.76 to 12.3
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=20 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=20 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Visceral Adipose Tissue
|
231 cm^2
Interval 145.0 to 327.0
|
233 cm^2
Interval 142.0 to 318.0
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=19 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=18 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Liver Fat
|
6 percentage of intrahepatic lipid
Interval 3.0 to 13.0
|
4 percentage of intrahepatic lipid
Interval 2.0 to 9.0
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=20 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=20 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Intramyocellular Lipid
|
0.4 percentage of intramyocellular lipid
Interval 0.2 to 0.6
|
0.4 percentage of intramyocellular lipid
Interval 0.3 to 0.4
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=20 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=17 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Flow Mediated Vasodilation
|
15.3 percentage of maximum change
Interval 7.7 to 17.3
|
9.6 percentage of maximum change
Interval 6.9 to 20.4
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=22 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=20 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Potassium
|
4.2 mEq/L
Standard Error 0.1
|
4.2 mEq/L
Standard Error 0.0
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=22 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=20 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Hemoglobin A1c
|
5.7 percentage
Interval 5.4 to 6.0
|
5.8 percentage
Interval 5.4 to 5.9
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=21 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=18 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
C-Reactive Protein
|
2.8 mg/L
Interval 1.7 to 5.8
|
2.8 mg/L
Interval 0.9 to 10.3
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=21 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=18 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Plasminogen Activator Inhibitor 1
|
35 ng/mL
Standard Error 3
|
35 ng/mL
Standard Error 3
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Eplerenone and Lifestyle
n=21 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=18 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Adiponectin
|
4015 pg/mL
Interval 2926.0 to 5588.0
|
4014 pg/mL
Interval 3213.0 to 6012.0
|
SECONDARY outcome
Timeframe: 6 monthsIL-6
Outcome measures
| Measure |
Eplerenone and Lifestyle
n=21 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=17 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Markers of Systemic Inflammation
|
9.8 pg/mL
Interval 4.8 to 16.6
|
8.9 pg/mL
Interval 6.3 to 27.8
|
SECONDARY outcome
Timeframe: 6 monthsMCP-1
Outcome measures
| Measure |
Eplerenone and Lifestyle
n=21 Participants
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=18 Participants
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Markers of Immune Activation
|
205 pg/mL
Standard Error 19
|
210 pg/mL
Standard Error 17
|
Adverse Events
Eplerenone and Lifestyle
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo and Lifestyle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eplerenone and Lifestyle
n=25 participants at risk
First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)
Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling
|
Placebo and Lifestyle
n=21 participants at risk
First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification
placebo and lifestyle: placebo pill daily and lifestyle counseling
|
|---|---|---|
|
Renal and urinary disorders
Elevated Creatinine
|
4.0%
1/25 • Number of events 1 • 6 months
|
4.8%
1/21 • Number of events 1 • 6 months
|
|
Cardiac disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • 6 months
|
4.8%
1/21 • Number of events 1 • 6 months
|
|
Cardiac disorders
Hypertension
|
0.00%
0/25 • 6 months
|
9.5%
2/21 • Number of events 2 • 6 months
|
|
General disorders
Headache
|
0.00%
0/25 • 6 months
|
4.8%
1/21 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
2/25 • Number of events 2 • 6 months
|
0.00%
0/21 • 6 months
|
|
Gastrointestinal disorders
Anorexia
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
|
Gastrointestinal disorders
Rectal Bleed
|
8.0%
2/25 • Number of events 2 • 6 months
|
0.00%
0/21 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
16.0%
4/25 • Number of events 4 • 6 months
|
28.6%
6/21 • Number of events 6 • 6 months
|
|
Infections and infestations
Other Infection
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
|
Renal and urinary disorders
Urinary Symptoms
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.0%
1/25 • Number of events 1 • 6 months
|
9.5%
2/21 • Number of events 2 • 6 months
|
|
Psychiatric disorders
Mood Symptoms
|
4.0%
1/25 • Number of events 1 • 6 months
|
4.8%
1/21 • Number of events 1 • 6 months
|
|
General disorders
Insomnia
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/21 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place