ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV. Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
CAP Research Ltd
Curepipe, Mauritius
HIV-NAT, Thai Red Cross AIDS Research Center
Bangkok, Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand
Safety and tolerability profile of ABX464 as assessed by the change from baseline in laboratory values, in vital signs and ECG parameters at week 3 and by the number of patients with adverse events.
Number of patients with abnormal blood (hematology and biochemistry) and urinary laboratory values, abnormal vital signs and ECG parameters and the number/proportion of patients reporting any adverse event.
Time frame: Week 3
Cmax
Maximum concentration in plasma of ABX464 and metabolite
Time frame: week 1, week 2 and week 3
tmax
Time to maximum concentration
Time frame: Week 3
AUC
Area under the concentration-time curve
Time frame: Week 3
t1/2
Half-life of the ABX464 in plasma
Time frame: Week 3
Pharmacodynamic activity as expressed by CD4 and CD8 count
CD4 and CD8 values
Time frame: Week 3
Pharmacodynamic activity as expressed by HIV viral load
HIV viral load across time and possible relationship with PK parameters
Time frame: Week 3
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