Trial reportJournal of acquired immune deficiency syndromes (1999)2013
Influence of low-dose ritonavir with and without darunavir on the pharmacokinetics and pharmacodynamics of inhaled beclomethasone.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- Prevalence of potentially inappropriate medications in people living with HIV: a systematic review and meta-analysis.BMC infectious diseases · 2025Pooled it
- Article
- Chronic Obstructive Pulmonary Disease in People with HIV: an Evidence-Based Review.HIV/AIDS (Auckland, N.Z.) · 2025Review
- Orthostatic hypotension in a patient with HIV: uncovering adrenal insufficiency from fluticasone-cobicistat interactions.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2024Article
- Efficacy/Safety of the Use of Glucocorticoids in Oral and Maxillofacial Surgery.Dentistry journal · 2023Review
- HIV-associated lung disease.Nature reviews. Disease primers · 2023Review
- Treating asthma in the time of COVID.The Journal of allergy and clinical immunology · 2023Article
- Article
- Chronic obstructive pulmonary disease in HIV.Expert review of respiratory medicine · 2021Review
- Pharmacokinetics of inhaled nanotherapeutics for pulmonary delivery.Journal of controlled release : official journal of the Controlled Release Society · 2020Review
- Pharmacokinetic Drug-Drug Interactions Between Immunosuppressant and Anti-Infective Agents: Antimetabolites and Corticosteroids.Annals of transplantation · 2018Review
- Iatrogenic Cushing's syndrome due to drug interaction between glucocorticoids and the ritonavir or cobicistat containing HIV therapies.Clinical medicine (London, England) · 2016Article
- Obstructive Lung Diseases in HIV: A Clinical Review and Identification of Key Future Research Needs.Seminars in respiratory and critical care medicine · 2016Review
- Dosing Recommendations for Concomitant Medications During 3D Anti-HCV Therapy.Clinical pharmacokinetics · 2016Review
- Adrenal suppression in patients taking inhaled glucocorticoids is highly prevalent and management can be guided by morning cortisol.European journal of endocrinology · 2015Article
- HIV-associated obstructive lung diseases: insights and implications for the clinician.The Lancet. Respiratory medicine · 2014Review
- Pathogenesis and management of emphysema in people with HIV.Expert review of respiratory medicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo identify an alternative inhaled corticosteroid to fluticasone propionate that can be safely coadministered with HIV protease inhibitors, the safety and pharmacokinetics of beclomethasone dipropionate (BDP) and its active metabolite, beclomethasone 17-monopropionate (17-BMP), in combination with ritonavir (RTV) and darunavir/ritonavir (DRV/r) were assessed.
designOpen-label, prospective, randomized pharmacokinetic and pharmacodynamic study in healthy volunteers.
methodsThirty healthy volunteers received inhaled 160 μg bid BDP for 14 days and were then randomized (1:1:1) into 3 groups: group 1 (control) remained on BDP alone for 28 days, group 2 received 100 mg bid BDP + RTV for 28 days, and group 3 received 600/100 mg bid BDP + DRV/r for 28 days. Pharmacokinetic sampling for 17-BMP was performed on days 14 and 28, and pharmacokinetic parameter values were compared within patients and between groups. Cortisol stimulation testing was also performed on days 1, 14, 28, and 42 and compared within and between groups.
resultsGeometric mean ratios (day 28:day 14) (90% confidence interval) for 17-BMP area under the concentration-time curve in groups 1, 2, and 3, respectively, were 0.93 (0.81 to 1.06, P = 0.27), 2.08 (1.52 to 2.65, P = 0.006), and 0.89 (0.68 to 1.09, P = 0.61). There were no significant reductions in serum cortisol levels within or between groups (P > 0.05).
conclusionsDRV/r did not increase 17-BMP exposure, whereas RTV alone produced a statistically significant but clinically inconsequential 2-fold increase in 17-BMP exposure. Adrenal suppression was not observed in any of the study groups. These data suggest that BDP can be safely coadministered with DRV/r and likely other RTV-boosted protease inhibitors.
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Registered trials
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