title: Twice-weekly dapsone for primary prophylaxis against Pneumocystis carinii pneumonia in HIV-1 infection: efficacy, safety and pharmacokinetic data.
abstract: OBJECTIVES: In this study we evaluated the pharmacokinetics, efficacy and safety of dapsone given 100 mg twice weekly as primary prophylaxis against Pneumocystis carinii pneumonia (PCP) in patients with HIV-1 infection. METHODS: This was a prospective open trial, evaluating a total of 55 HIV-1-infected patients with CD4 cell counts below 200/mm3 and without previous episodes of PCP. Plasma concentrations of dapsone were determined with high-performance liquid chromatography (HPLC). After a mean follow-up of 471 days, the PCP rates per year of observation were 6.79%. Discontinuation of treatment as a result of severe side effects was required in four patients (7.5%). At steady state, mean plasma concentrations 24, 72, 96 and 144 h following the administration of dapsone were 1.46plus minus0.8, 0.28plus minus0.20, 0.30plus minus0.21 and 0.37plus minus0.27 mg/L, respectively. Dapsone plasma levels showed a high interpatient variability. The values for the pharmacokinetic parameters were comparable to those described for healthy volunteers. CONCLUSIONS: The administration of 100 mg twice weekly of dapsone seems appropriate to maintain effective plasma concentrations of the drug and to prevent PCP with good safety in patients with HIV-1-related immunodeficiency.
authors.affiliation: Institute of Immunology and Infectious Diseases, Verona, Italy.
authors.forename: M.
authors.initials: M
authors.lastname: Cruciani
authors.forename: E.
authors.initials: E
authors.lastname: Bertazzoni Minelli
authors.forename: M.
authors.initials: M
authors.lastname: Mirandola
authors.forename: R.
authors.initials: R
authors.lastname: Luzzati
authors.forename: M.
authors.initials: M
authors.lastname: Merighi
authors.forename: L.
authors.initials: L
authors.lastname: Lazzarini
authors.forename: G.
authors.initials: G
authors.lastname: Gatti
authors.forename: S.
authors.initials: S
authors.lastname: Vento
authors.forename: R.
authors.initials: R
authors.lastname: Mazzi
authors.forename: M.
authors.initials: M
authors.lastname: Malena
authors.forename: A.
authors.initials: A
authors.lastname: Benini
authors.forename: A.
authors.initials: A
authors.lastname: Cazzadori
authors.forename: G.
authors.initials: G
authors.lastname: Piemonte
authors.forename: D.
authors.initials: D
authors.lastname: Bassetti
authors.forename: E.
authors.initials: E
authors.lastname: Concia