Egrifta Replacement and Sleep Disordered Breathing

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Philip L. Smith ll MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01788462
First received: February 1, 2013
Last updated: February 8, 2013
Last verified: February 2013

February 1, 2013
February 8, 2013
Not Provided
January 2014   (final data collection date for primary outcome measure)
  • Changes in Sleep Apnea Severity [ Time Frame: Subjects will be evaluated prior to initiating tesamorelin therapy (baseline) ] [ Designated as safety issue: No ]
    Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.
  • Changes in Sleep Apnea Severity [ Time Frame: Subjects will be evaluated at three months ] [ Designated as safety issue: No ]
    Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.
  • Changes in Sleep Apnea Severity [ Time Frame: Subjects will be evaluated at six months ] [ Designated as safety issue: No ]
    Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.
  • Changes in Sleep Apnea Severity [ Time Frame: Subjects will be evaluated at one year ] [ Designated as safety issue: No ]
    Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.
Same as current
Complete list of historical versions of study NCT01788462 on ClinicalTrials.gov Archive Site
  • Changes in Body Composition [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Secondary outcomes will include the percent change in anthropometric and body composition parameters as reflected by Dual-Energy Xray Absorbtiometry measurements.
  • Changes in Body Composition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Secondary outcomes will include the percent change in anthropometric and body composition parameters as reflected by Dual-Energy Xray Absorbtiometry measurements.
Same as current
Not Provided
Not Provided
 
Egrifta Replacement and Sleep Disordered Breathing
Egrifta Replacement and Sleep Disordered Breathing

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood

Non-Probability Sample

Men and women with HIV infection and central lipohypertrophy about to start tesamorelin therapy will be recruited from the Endocrinology Clinic at the Johns Hopkins Outpatient Center. Physicians and members of the clinical staff will identify eligible men and briefly introduce the study to them. Patients will be offered a phone number for the Johns Hopkins Sleep Disorders Center to call if they are interested in learning more about the research study.

Lipodystrophy
Drug: Tesamorelin (Egrifta)
We will observe the effects of Tesamorelin on patients with HIV and lipodystrophy.
Other Name: Egrifta TM
HIV and Lipodystrophy
The study population will consist of HIV patients with lipodystrophy who receive Tesamorelin (Egrifta).
Intervention: Drug: Tesamorelin (Egrifta)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Not Provided
January 2014   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 75 Years
No
Contact: Michelle Guzman 410-550-6336 mguzman4@jhmi.edu
Contact: Erin Hawks 410-550-2764 ihawks@jhu.edu
United States
 
NCT01788462
NA_00074675
No
Philip L. Smith ll MD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Philip L Smith, M.D. Johns Hopkins University
Johns Hopkins University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP