This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive adults. There are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
In Cohort 1, the subjects who were randomized to get active product will receive deferiprone at a dose of 1.5 g per infusion, and if there are no significant safety concerns, the subjects in Cohort 2 who were randomized to get active product will receive it a a dose of 2 g per infusion.
In both cohorts, the subjects who were randomized to get placebo will receive an infusion of placebo solution that is equal in volume to that of the active product.
Phoenix Pharma
Port Elizabeth, Eastern Cape, South Africa
VxPharma
Pretoria, South Africa
Change from baseline in HIV viral load
Time frame: Day 1 to Day 56
Change from baseline in CD4+ T-cell count
Time frame: Day 1 to Day 56
Change from baseline in level of HIV DNA in peripheral blood mononucleated cells
Time frame: Day 1 to Day 56
Proportion of subjects withdrawn due to the need for rescue medication
Time frame: Day 1 to Day 56
Number of subjects with adverse events
Time frame: Day 1 to Day 56
The pharmacokinetics parameters of Cmax, Tmax, and AUC0-∞, and T1/2 for deferiprone will be determined pre-dose and at specified time points post-dose
Time frame: 10-hour interval
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