Adrenal Insufficiency Clinical Trial
Official title:
Inhalation or Nasal Corticosteroids and Prevalence of Hypothalamic-pituitary-adrenal Axis Suppression in HIV-infected Patients
Rationale: Case reports describe suppression of the hypothalamic-pituitary-adrenal (HPA)
axis caused by local corticosteroids, most often with inhalation corticosteroids. The exact
prevalence is not known. Early recognition is important, because suppression of the HPA-axis
can lead to significant morbidity and mortality. Suppression of the HPA axis might occur
more often when a Cytochrome P450 3A4 (CYP3A4) inhibitor, e.g. ritonavir, is used next to
the local corticosteroid, a combination often used by human immunodeficiency virus
(HIV)-patients. Cortisol can be determined in hair. This non-invasive analysis could help in
diagnosis of suppressed HPA-axis.
Research questions:
Primary objective:
1. How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis
in HIV-treated patients?
Secondary objectives:
2. Are other variables associated with the HPA-axis suppression?
3. Are cortisol measurements in hair as reliable as serum cortisol or an
Adrenocorticotropic hormone (ACTH) stimulation test to diagnose suppression of the HPA
axis? Study design: cross-sectional explorative study Study population: adults treated
for HIV and using an inhalation or nasal corticosteroid.
Intervention: an ACTH stimulation test, cortisol measurements in blood and hair.
Main study parameters/endpoints:
Proportions of persons with a low morning plasma cortisol or low cortisol after an ACTH
stimulation test. Correlation between cortisol in plasma and hair cortisol.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Each person will be screened with a history and a short physical examination. A
venous cannula will be inserted for obtaining blood for the plasma cortisol and for the ACTH
stimulation test. An ACTH stimulation test has no major complications. A piece of hair is
cut for cortisol hair analysis. The risks and burden are minimal, while the future benefits
could be great since suppression of the endogenous HPA- axis can be associated with
morbidities like hypertension or osteoporosis and can even lead to an adrenal crisis when
the local corticosteroid is stopped.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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