Beclomethasone Study
Study name
Drug Interaction Study Between Orally Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers
Study number
09-CC-0186
Goal of Study
The NIH is conducting a drug interaction study between an inhaled steroid, beclomethasone (Qvar®), and two protease inhibitors used to treat HIV, darunavir (Prezista®) and ritonavir (Norvir®). The amount of inhaled beclomethasone that usually enters the bloodstream is small and is quickly removed from the body before causing side effects. Unlike with inhaled fluticasone, another medication often used as an inhaler, beclomethasone uses a different pathway to enter and exit the bloodstream which is generally not affected by the protease inhibitors. Therefore, we do not believe that ritonavir with or without darunavir will increase the amount of beclomethasone that reaches the bloodstream. We also do not believe that protease inhibitors will delay the removal of beclomethasone from the body. Because we believe there will be no significant interaction between beclomethasone and protease inhibitors, we do not believe this combination will change the function of the adrenal glands. Results from this study will help determine if inhaled beclomethasone is a safe treatment for patients with breathing problems who are also taking ritonavir with or without darunavir.
Study Regimen
We will recruit 46 subjects. Volunteers will inhale two puffs of beclomethasone per day for 28 days. At day 14, volunteers will have a 12-hour blood draw visit, with blood taken seven times in that period. Subjects in Group A (18 subjects) will take beclomethasone alone, twice daily, for an additional 28 days; Group B (14 subjects) will take beclomethasone twice a day, along with ritonavir, 100mg. twice a day for 28 days; Group C (14 subjects) will take beclomethasone, ritonavir and add darunavir, 600 mg, twice a day for 28 days. At day 28, all groups will have another 12-hour blood draw visit. All medications for all groups will stop on day 46, after the testing of adrenal functions and other blood draws. Volunteers will be compensated.
Eligibility Criteria
- You are age 18-50 years old, and are HIV-negative
- You are healthy, and do not routinely take prescription or over-the-counter medications
- You are not pregnant, and you do not take hormone-based contraceptives
- You are a non-smoker
- You have adequate veins for blood collection
- You do not abuse drugs or alcohol
- You can commit the time to the blood draw days
For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office
Toll Free: 1-800-411-1222
TTY: 1-866-411-1010
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Office hours: 8 am to 8 pm, Eastern Time |
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