Inhalation/Nasal Corticosteroids and Prevalence of Hypothalamic-pituitary-adrenal (HPA) Axis Suppression in Human Immunodeficiency Virus (HIV)-Patients (Incorporate)
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|ClinicalTrials.gov Identifier: NCT02501486|
Recruitment Status : Unknown
Verified October 2016 by Radboud University.
Recruitment status was: Recruiting
First Posted : July 17, 2015
Last Update Posted : October 13, 2016
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.
How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis in HIV-treated patients?
- Are other variables associated with the HPA-axis suppression?
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Adrenal Insufficiency||Other: ACTH stimulation test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inhalation or Nasal Corticosteroids and Prevalence of Hypothalamic-pituitary-adrenal Axis Suppression in HIV-infected Patients|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||February 2017|
ACTH stimulation test
this is a single arm study. An ACTH-stimulation test will be done
Other: ACTH stimulation test
An ACTH stimulation test will be done
- the percentage of participants with a morning serum cortisol below 80 nmol/L in morning or below 550 nmol/L after Adrenocorticotropic (ACTH) stimulation test [ Time Frame: baseline ]these are the persons with hypothalamic-pituitary-adrenal (HPA) -axis suppression
- Difference in percentage of HPA-axis suppression in participants who use a Cytochrome P450 3A4 (CYP3a4) inhibitor (ritonavir or cobicistat) versus percentage of HPA-axis suppression in participants who don't use a booster [ Time Frame: baseline ]HPA-axis suppression is described in outcome 1. If the investigators have enough data the following will also be analysed: duration of usage of inhalation/nasal corticosteroids and use of systemical corticosteroid before (never versus ever used).
- Percentage of HPA-axis suppression stratified by type of corticosteroid [ Time Frame: baseline ]HPA-axis suppression is described in outcome 1. If the investigators have enough data the following will also be analysed: duration of usage of inhalation/nasal corticosteroids and use of systemical corticosteroid before (never versus ever used).
- Difference in percentage of HPA-axis suppression in persons who use a high dose of corticosteroids versus a low dose of corticosteroids [ Time Frame: baseline ]
- Cortisol measurements in hair to diagnose HPA-axis suppression, in comparison with serum cortisol or an ACTH stimulation test [ Time Frame: baseline ]hair cortisol measurements are given in pg/mg hair.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501486
|Contact: F Besemer||0031243614599|
|Onze lieve vrouw Gasthuis||Recruiting|
|Principal Investigator:||David Burger, Prof||Radboud UMC Pharmacy|