Trial Outcomes & Findings for Cardiometabolic Effects of Eplerenone in HIV Infection (NCT NCT02629094)
NCT ID: NCT02629094
Last Updated: 2018-07-17
Results Overview
Mean change in intraventricular septum percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline intraventicular septum percentage value of lipid from the week 24 intraventicular septum percentage value of lipid by MR spectroscopy.
TERMINATED
PHASE2
5 participants
24 weeks
2018-07-17
Participant Flow
Participant milestones
| Measure |
Eplerenone
Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiometabolic Effects of Eplerenone in HIV Infection
Baseline characteristics by cohort
| Measure |
Eplerenone
n=8 Participants
Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Analyses included participants who completed 24 weeks on study drug eplerenone.
Mean change in intraventricular septum percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline intraventicular septum percentage value of lipid from the week 24 intraventicular septum percentage value of lipid by MR spectroscopy.
Outcome measures
| Measure |
Eplerenone
n=5 Participants
Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
|
|---|---|
|
Improvement of Cardiac Steatosis: Mean Change in Intraventricular Septum Percentage of Lipid by MR Spectroscopy.
|
-0.33 percentage of lipid
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Analyses included participants who completed 24 weeks on study drug eplerenone.
Mean change in hepatic percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline hepatic percentage value of lipid from the week 24 hepatic percentage value of lipid by MR spectroscopy.
Outcome measures
| Measure |
Eplerenone
n=5 Participants
Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
|
|---|---|
|
Improvement of Hepatic Steatosis: Mean Change in Hepatic Percentage of Lipid by MR Spectroscopy
|
13 percentage of lipid
Standard Deviation 7.3
|
Adverse Events
Eplerenone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eplerenone
n=5 participants at risk
Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
|
|---|---|
|
Infections and infestations
Acute sinusitis
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Investigations
Blood bicarbonate decreased
|
40.0%
2/5 • Number of events 2 • 32 weeks
|
|
Investigations
Blood calcium increased
|
20.0%
1/5 • Number of events 3 • 32 weeks
|
|
Investigations
Blood creatinine increased
|
20.0%
1/5 • Number of events 2 • 32 weeks
|
|
Investigations
Blood glucose increased
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Investigations
Blood magnesium decreased
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Investigations
Blood phosphorus decreased
|
40.0%
2/5 • Number of events 2 • 32 weeks
|
|
Investigations
Blood potassium decreased
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Investigations
Blood sodium decreased
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Investigations
Blood triglycerides increased
|
20.0%
1/5 • Number of events 2 • 32 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Investigations
Low density lipoprotein increased
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Infections and infestations
Nasopharyngitis
|
40.0%
2/5 • Number of events 2 • 32 weeks
|
|
Immune system disorders
Seasonal allergy
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Gastrointestinal disorders
Tooth disorder
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • 32 weeks
|
Additional Information
Hadigan, Colleen
National Institute of Allergy and Infectious Diseases
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place