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Trial record 16 of 112 for:    EPLERENONE

Cardiometabolic Effects of Eplerenone in HIV Infection

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ClinicalTrials.gov Identifier: NCT02629094
Recruitment Status : Terminated
First Posted : December 14, 2015
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiac Steatosis
Hepatic Steatosis
Intervention Drug: Inspra /Eplerenone
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eplerenone
Hide Arm/Group Description Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Eplerenone
Hide Arm/Group Description Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
All screened participants were evaluated for baseline data, of which 5 were eligible to start.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  87.5%
>=65 years
1
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  62.5%
White
2
  25.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Improvement of Cardiac Steatosis: Mean Change in Intraventricular Septum Percentage of Lipid by MR Spectroscopy.
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included participants who completed 24 weeks on study drug eplerenone.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percentage of lipid
-0.33  (4.3)
2.Primary Outcome
Title Improvement of Hepatic Steatosis: Mean Change in Hepatic Percentage of Lipid by MR Spectroscopy
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included participants who completed 24 weeks on study drug eplerenone.
Arm/Group Title Eplerenone
Hide Arm/Group Description:
Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percentage of lipid
13  (7.3)
Time Frame 32 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eplerenone
Hide Arm/Group Description Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks
All-Cause Mortality
Eplerenone
Affected / at Risk (%)
Total   0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eplerenone
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Gastrointestinal disorders   
Tooth disorder   1/5 (20.00%)  1
Immune system disorders   
Seasonal allergy   1/5 (20.00%)  1
Infections and infestations   
Acute sinusitis   1/5 (20.00%)  1
Nasopharyngitis   2/5 (40.00%)  2
Upper respiratory tract infection   1/5 (20.00%)  1
Investigations   
Blood bicarbonate decreased   2/5 (40.00%)  2
Blood calcium increased   1/5 (20.00%)  3
Blood creatinine increased   1/5 (20.00%)  2
Blood glucose increased   1/5 (20.00%)  1
Blood magnesium decreased   1/5 (20.00%)  1
Blood phosphorus decreased   2/5 (40.00%)  2
Blood potassium decreased   1/5 (20.00%)  1
Blood sodium decreased   1/5 (20.00%)  1
Blood triglycerides increased   1/5 (20.00%)  2
Low density lipoprotein increased   1/5 (20.00%)  1
Metabolism and nutrition disorders   
Hypertriglyceridaemia   1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Eczema   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hadigan, Colleen
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 301 594 5754
EMail: hadiganc@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT02629094     History of Changes
Other Study ID Numbers: 160030
16-I-0030
First Submitted: December 10, 2015
First Posted: December 14, 2015
Results First Submitted: May 7, 2018
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018