Inhalation or nasal corticosteroids and prevalence of hypothalamic-pituitary-adrenal axis suppression in HIV-infected patients

Completed

• Conditions: adrenal insufficiency; 10001353

• Registration Number: NL-OMON42012
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportions of persons with a low morning plasma cortisol or low cortisol after<br /><br>an ACTH stimulation test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>b. Proportions of persons with a low morning plasma cortisol or low cortisol<br /><br>after an ACTH stimulation test, stratified e.g. by kind of inhalation<br /><br>corticosteroid, dosage of local corticosteroid and use/no use of CYp3A4<br /><br>inhibitor.<br /><br>c. Correlation between cortisol in plasma and hair cortisol. </p><br>