The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of different dosages of deferiprone in subjects with or without HIV infection.
Three cohorts were enrolled: two of individuals who were asymptomatically infected with HIV and one of healthy volunteers. Dosages were as follows: * Cohort 1 (asymptomatic HIV infected subjects): 33 mg/kg deferiprone three times daily for a total of 99 mg/kg/day * Cohort 2 (healthy volunteers): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day * Cohort 3 (asymptomatic HIV infected subjects): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
26
Oral iron chelator
PAREXEL International
Bloemfontein, South Africa
Occurrence of adverse events following repeated oral doses of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers
Collection of adverse events, including abnormal findings in physical examination, vital signs, 12-lead ECG, 24-hour Holter ECG, and laboratory variables (hematology, clinical chemistry, and urinalysis)
Time frame: 9 weeks (from receipt of first dose until 8 weeks after the last dose)
Measurement of viral load following repeated oral doses of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers
Measurement of HIV RNA load for the assessment of antiretroviral activity
Time frame: 9 weeks (pre-dose until 8 weeks after last dose)
Cluster of differentiation 4 (CD4) count and p24 antigen status following repeated oral doses of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers
Measurement of CD4 count and p24 antigen status for assessment of antiviral activity
Time frame: 1 week (pre-dose to day of last dose)
Cmax of deferiprone and deferiprone 3-O-glucuronide
Determination of Cmax following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers
Time frame: 24-hour interval
Tmax of deferiprone and deferiprone 3-O-glucuronide
Determination of Tmax of deferiprone and its metabolite following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers
Time frame: 24-hour interval
Area under the curve (AUC) 0-infinity of deferiprone and deferiprone 3-O-glucuronide
Determination of AUC 0-infinity of deferiprone and its metabolite following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers
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Time frame: 24-hour interval
T1/2 of deferiprone and deferiprone 3-O-glucuronide
Determination of T1/2 of deferiprone and its metabolite following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers
Time frame: 24-hour interval