Primary objective:a. How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis in HIV-treated patients? Secondary objectives:b. Are other variables associated with the HPA-axis suppression? c. Are cortisol measurements in…
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportions of persons with a low morning plasma cortisol or low cortisol after
an ACTH stimulation test.
Secondary outcome
b. Proportions of persons with a low morning plasma cortisol or low cortisol
after an ACTH stimulation test, stratified e.g. by kind of inhalation
corticosteroid, dosage of local corticosteroid and use/no use of CYp3A4
inhibitor.
c. Correlation between cortisol in plasma and hair cortisol.
Background summary
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 CYP3A4 inhibitor, e.g. ritonavir, is used next to the local
corticosteroid, a combination often used by HIV-patients. Cortisol can be
determined in hair. This non-invasive analysis could help in diagnosis of
suppressed HPA-axis.
Study objective
Primary objective:
a. How often do inhalation or nasal corticosteroids lead to suppression of the
HPA- axis in HIV-treated patients?
Secondary objectives:
b. Are other variables associated with the HPA-axis suppression?
c. Are cortisol measurements in hair as reliable as serum cortisol or an ACTH
stimulation test to diagnose suppression of the HPA axis?
Study design
cross-sectional explorative study
Intervention
an ACTH stimulation test, cortisol measurements in blood and hair.
Study burden and risks
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.
geert-grooteplein zuid/10 geert-grooteplein/471
nijmegen 6525ga
NL
geert-grooteplein zuid/10 geert-grooteplein/471
nijmegen 6525ga
NL
Listed location countries
Age
Inclusion criteria
- Receive a treatment for HIV-infection
- > 18 years old
- Current usage of inhalation or nasal corticosteroids
- Willing to give informed consent
Exclusion criteria
- Known adrenal insufficiency
- Concurrent use of topical corticosteroids, usage of oral corticosteroids in the last three months. Intramuscular or intra-articular corticosteroid injections in the last year.
- Contra-indications for tetracosactide: allergy for tetracosactide, Cushings*s syndrome, refractory heart failure, peptic ulcer, acute psychosis, adrenogenital syndrome
- Pregnant female or breast-feeding female.
- Use of oral contraceptives, since these can heighten the cortisol-binding globulin
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51711.091.14 |