Egrifta Replacement and Sleep Disordered Breathing

Lipodystrophy Clinical Trial

Official title:

Egrifta Replacement and Sleep Disordered Breathing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01788462
• Other study ID #: NA_00074675
• Status: Withdrawn
• Phase: N/A
• First received: February 1, 2013
• Last updated: March 2, 2017
• Start date: May 2012

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Lipodystrophy

Intervention

Drug:
• Tesamorelin (Egrifta)
We will observe the effects of Tesamorelin on patients with HIV and lipodystrophy.

Locations

Country	Name	City	State
United States	Johns Hopkins Sleep Disorders Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Sleep Apnea Severity	Sleep apnea severity (AHI), change in sleep apnea severity (? AHI), and compensatory neuromuscular responses (AT/DBT, ? AT/DBT) will be the primary outcome variables.	Subjects will be evaluated prior to initiating tesamorelin therapy (baseline)
Primary	Changes in Sleep Apnea Severity	Sleep apnea severity (AHI), change in sleep apnea severity (? AHI), and compensatory neuromuscular responses (AT/DBT, ? AT/DBT) will be the primary outcome variables.	Subjects will be evaluated at three months
Primary	Changes in Sleep Apnea Severity	Sleep apnea severity (AHI), change in sleep apnea severity (? AHI), and compensatory neuromuscular responses (AT/DBT, ? AT/DBT) will be the primary outcome variables.	Subjects will be evaluated at six months
Primary	Changes in Sleep Apnea Severity	Sleep apnea severity (AHI), change in sleep apnea severity (? AHI), and compensatory neuromuscular responses (AT/DBT, ? AT/DBT) will be the primary outcome variables.	Subjects will be evaluated at one year
Secondary	Changes in Body Composition	Secondary outcomes will include the percent change in anthropometric and body composition parameters as reflected by Dual-Energy Xray Absorbtiometry measurements.	baseline
Secondary	Changes in Body Composition	Secondary outcomes will include the percent change in anthropometric and body composition parameters as reflected by Dual-Energy Xray Absorbtiometry measurements.	12 months