Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers

This is an interventional prevention trial for HIV focused on measuring Drug Interaction, Asthma, HIV, Beclomethasone, Protease Inhibitors, HV, Healthy Volunteer, HIV Infections Read More

• INCLUSION CRITERIA:

  1. Males and females between the ages of 18 and 60 years
  2. Healthy by medical history and physical examination
  3. Laboratory values within established guidelines for participation in clinical studies: aspartate transaminase (AST) less than or equal to 2 times the ULN; serum creatinine less than or equal to the ULN; hemoglobin greater than or equal to 11 g/dL (for both males and females)
  4. Negative serum or urine pregnancy test for females of child-bearing potential
  5. Females of child-bearing potential who are able and willing to practice abstinence or use non-hormonal effective methods of birth control during the study, such as condoms or diaphragms

EXCLUSION CRITERIA:

1. Concomitant routine therapy with any prescription, over-the-counter, herbal, or holistic medications, including hormonal contraceptives by any route, any corticosteroid by any route, any inhaled medications, and any investigational drugs, for 30 days prior to study participation. An exception to this requirement is the use of topical medications that are not significantly absorbed systemically, e.g. topical minoxidil.

   • Concomitant therapy (chronic or intermittent) with any prescription, over-the-counter, or herbal drugs will not be allowed during the study duration
   • Intermittent use of acetaminophen, non-steroidal anti-inflammatory medications (i.e., ibuprofen), and loperamide will be allowed to be taken according to each manufacturer's recommendations during the study, but should not be taken on the days of pharmacokinetic blood sampling
   • A daily multivitamin with minerals will be allowed during the study
   • Use of topical medications that are not significantly absorbed systemically wil be allowed if approved by the Principal Investigator.
2. Inability to obtain venous access for blood sample collection

3. The presence or history of any of the following:

   • adrenal disease (e.g., Addison's disease, Cushing's syndrome, etc.),
   • diabetes mellitus (clinical diagnosis based on current guidelines),
   • HIV infection,
   • pulmonary disease (e.g., asthma, chronic obstructive pulmonary disease, etc.),
   • cardiac disease (e.g., hypertension [systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg], heart failure, arrhythmia, etc.),
   • renal disease (chronic or acute renal failure or insufficiency),
   • hepatitis (as assessed by patient interview) or hepatic impairment,
   • pancreatitis,
   • bleeding disorders (e.g., hemophilia),
   • internal bleeding (such as gastrointestinal or intracranial),
   • peptic ulcer disease requiring maintenance pharmacologic therapy,
   • osteoporosis,
   • osteonecrosis,
   • atopy or atopic dermatitis,
   • hormone-sensitive cancers or conditions,
   • malignancy,
   • organ transplant,
   • seizure disorders,
   • schizophrenia or other psychiatric illnesses that may interfere with the subject's ability to participate in the study, or
   • any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the investigators.
4. Baseline cortisol level less than 5 mcg/dL
5. Positive serum or urine pregnancy test or breastfeeding female
6. The presence of persistent diarrhea or malabsorption that would interfere with the subject's ability to absorb drugs
7. Drug or alcohol abuse that may impair safety or adherence
8. History of intolerance or allergic reaction to darunavir, ritonavir, beclomethasone, cosyntropin, or any inhaled medication
9. Fasting total cholesterol greater than 240 mg/dL or fasting triglycerides greater than 400 mg/dL
10. Fasting glucose greater than100 mg/dL
11. Use of nicotine-containing tobacco products, including cigarettes and chewing tobacco