NCT01405456

Brief Summary

The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. In this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. The investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 16, 2018

Completed
Last Updated

June 15, 2018

Status Verified

May 1, 2018

Enrollment Period

5.3 years

First QC Date

July 27, 2011

Results QC Date

April 16, 2018

Last Update Submit

May 16, 2018

Conditions

HIV

Keywords

HIV-infectioneplerenonealdosteronevisceral fatlipodystrophy

Outcome Measures

Primary Outcomes (1)

  • Insulin Stimulated Glucose Uptake

    6 months

Secondary Outcomes (11)

  • Visceral Adipose Tissue

    6 months

  • Liver Fat

    6 months

  • Intramyocellular Lipid

    6 months

  • Flow Mediated Vasodilation

    6 months

  • Potassium

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Eplerenone and Lifestyle

EXPERIMENTAL

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)

Drug: Eplerenone and lifestyle

Placebo and Lifestyle

PLACEBO COMPARATOR

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

Other: placebo and lifestyle

Interventions

Eplerenone and lifestyleDRUG

eplerenone 50mg by mouth daily as well as lifestyle counseling

Eplerenone and Lifestyle
placebo and lifestyleOTHER

placebo pill daily and lifestyle counseling

Placebo and Lifestyle

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Increased waist circumference based on NCEP guidelines (\>102cm in men and \>88cm in women) and impaired glucose tolerance (either IFG \> 100 mg/dL but \< 126 mg/dL or 2hr glucose \> 140 mg/dl but \< 200 mg/dL, or fasting insulin \>12 uIU/mL)
  • HIV positive for 5y and on a stable ART regimen for at least 12 months
  • Age ≥ 30 and ≤ 65 years of age

You may not qualify if:

  • ACE Inhibitor, ARB, verapamil, or spironolactone
  • Potassium supplementation
  • Estimated GFR\<60, creatinine \> 1.5 mg/dL
  • Serum K \> 5.5 mEq/L, ALT \> 2.5 times the upper limit of normal, Hgb \< 11g/dL
  • Uncontrolled hypertension (SBP ≥ 160 or DBP ≥ 100)
  • Current or prior steroid use within past 6 months
  • Known history of diabetes mellitus or current use of anti-diabetic medications
  • Concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong inhibitors of CYP34A
  • Use of St. John's Wart (CYP3A4 inducer)
  • Pregnant or actively seeking pregnancy, breastfeeding
  • For women: Pregnant or actively seeking pregnancy, breastfeeding, failure to use an acceptable non-hormonal form of birth control, including abstinence, barrier contraceptives, or non-hormonal IUD.
  • Estrogen or progestational derivative use within 3 months
  • Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for \< 3 months.
  • Current growth hormone or growth hormone releasing hormone use
  • Current viral, bacterial or other infections (excluding HIV)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Srinivasa S, deFilippi C, Fitch KV, Iyengar S, Shen G, Burdo TH, Walpert AR, Thomas TS, Adler GK, Grinspoon SK. Evaluation of Mineralocorticoid Receptor Antagonism on Changes in NT-proBNP Among Persons With HIV. J Endocr Soc. 2021 Nov 19;6(1):bvab175. doi: 10.1210/jendso/bvab175. eCollection 2022 Jan 1.

    PMID: 34909518DERIVED

  • Srinivasa S, Fitch KV, Wong K, O'Malley TK, Maehler P, Branch KL, Looby SE, Burdo TH, Martinez-Salazar EL, Torriani M, Lyons SH, Weiss J, Feldpausch M, Stanley TL, Adler GK, Grinspoon SK. Randomized, Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Metabolic and Inflammatory Indices in HIV. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2376-2384. doi: 10.1210/jc.2018-00330.

    PMID: 29659888DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeLipodystrophy

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Steven K. Grinspoon
Organization
Massachusetts General Hospital
sgrinspoon@mgh.harvard.edu
6177249109

Study Officials

  • Steven Grinspoon, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 29, 2011

Study Start

January 1, 2012

Primary Completion

May 3, 2017

Study Completion

November 1, 2017

Last Updated

June 15, 2018

Results First Posted

May 16, 2018

Record last verified: 2018-05

Locations

US(1)