Egrifta Replacement and Sleep Disordered Breathing

Brief Title

Egrifta Replacement and Sleep Disordered Breathing

Official Title

Egrifta Replacement and Sleep Disordered Breathing

Brief Summary

      Sleep-disordered breathing is characterized primarily by partial or total upper airway
      obstruction during sleep. The most common form of sleep-disordered breathing is obstructive
      sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep
      state. The major risk factors associated with the development of sleep apnea are obesity and
      male sex. The investigators have also found a high prevalence of OSA in HIV infected men and
      women, particularly among those with central lipohypertrophy, which is a common finding in
      HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is
      that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters
      both mechanical properties and compensatory neuromuscular responses leading to upper airway
      obstruction. Based on our most recent findings in the non-HIV population, the investigators
      demonstrate that obesity is associated with elevations in the upper airway load (passive
      Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the
      investigators have found that female sex, peripheral adiposity, and younger age are
      associated with increased compensatory neuromuscular responses, while male sex, central
      adiposity, and older age are associated with blunted compensatory responses. The loss of the
      compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected
      patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing
      hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The
      investigators hypothesize that tesamorelin therapy will reverse both the mechanical and
      neurocompensatory alterations associated with increased central obesity. In this project the
      investigators will determine whether tesamorelin affects sleep apnea severity and
      compensatory neuromuscular responses of the upper airway on sleep and breathing in men and
      women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic
      basis for the development of obstructive sleep apnea in this population. The studies also
      provide insights into the neurohumoral regulation of upper airway function, and potentially
      new approaches to the treatment for sleep-disordered breathing.
    

Study Type

Observational

Primary Outcome

Changes in Sleep Apnea Severity

Secondary Outcome

 Changes in Body Composition

Condition

Lipodystrophy

Intervention

Tesamorelin (Egrifta)

Study Arms / Comparison Groups

 HIV and Lipodystrophy

Description:  The study population will consist of HIV patients with lipodystrophy who receive Tesamorelin (Egrifta).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

May 2012

Primary Completion Date

January 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Consenting adult with documented HIV-infection, ages 18 - 75 years old

          2. Central lipohypertrophy as determined by a clinician

          3. Not currently on Egrifta (tesamorelin) therapy.

        Exclusion Criteria:

          1. Unstable cardiovascular disease (decompensated CHF, myocardial infarction in past 3
             months, revascularization procedure in past 3 months, and unstable arrhythmias);

          2. Uncontrolled hypertension (BP > 190/110);

          3. Presence of cor pulmonale

          4. History of end stage renal disease (on dialysis);

          5. History of end stage liver disease ( e.g. jaundice, ascites, history of recurrent
             gastrointestinal bleeding, transjugular intrahepatic portosystemic shunt (TIPS) ;

          6. Bleeding disorders or coumadin use;

          7. Tracheostomy

          8. Active malignancy

          9. Pregnancy and/or nursing mother -
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Philip L Smith, M.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01788462

Organization ID

NA_00074675

Responsible Party

Principal Investigator

Study Sponsor

Johns Hopkins University

Study Sponsor

Philip L Smith, M.D., Principal Investigator, Johns Hopkins University

Verification Date

March 2017