The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics. The site will screen and enroll 12 HIV-infected subjects who will receive 150 mg ABX464 orally once daily for 28 days (Cohort 1). Following completion of this cohort a further 24 subjects will be enrolled: 12 HIV-uninfected subjects will receive 50 mg ABX464 orally once daily for 28 days (Cohort 2) and 12 HIV-infected subjects (Cohort 3) who will 50 mg ABX464 orally once daily for 84 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain
Area Under the Curve (AUC) of ABX464 in Sera
Pharmacokinetic parameters
Time frame: Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 in Sera
Pharmacokinetic parameters
Time frame: Day 1, Day 28 and day 84
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Pharmacokinetics parameters
Time frame: Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Pharmacokinetic parameters
Time frame: Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Pharmacokinetic parameters
Time frame: Day 1, Day 28 and Day 84
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Pharmacokinetic parameters
Time frame: Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Pharmacokinetic parameters
Time frame: Day 1, Day 28 and Day 84
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Pharmacokinetic parameters
Time frame: Day 1, Day 28 and Day 84
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Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Pharmacokinetic parameters
Time frame: Day 1, Day 28, Day 56, Day 84 and Day 112
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Pharmacokinetic parameters
Time frame: Day 1, Day 28, Day 56, Day 84 and Day 112
Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)
Viral Load Assessments (HIV-1 RNA copies/ml)
Time frame: Day 28, Day 56, Day 84 and Day 112
CD4+ Counts (Cell/mm^3)
T-cell determinations
Time frame: Day 28, Day 35, Day 56, Day 84, Day 91 and Day 112
Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)
HIV reservoir cells (CD4+)
Time frame: Day 28, Day 56, Day 84 and Day 112