Trial Outcomes & Findings for A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults (NCT NCT02990325)
NCT ID: NCT02990325
Last Updated: 2023-03-31
Results Overview
Pharmacokinetic parameters
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Day 1, Day 28 and Day 84
Results posted on
2023-03-31
Participant Flow
Participant milestones
| Measure |
ABX464 150mg
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults
Baseline characteristics by cohort
| Measure |
ABX464 150 mg Capsules for 28 Days
n=11 Participants
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50 mg Capsules for 28 Days
n=12 Participants
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50 mg Capsules for 84 Days
n=13 Participants
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Area Under the Curve (AUC) of ABX464 in Sera
Day 1
|
306.0 ng*h/mL
Geometric Coefficient of Variation 46.5
|
63.7 ng*h/mL
Geometric Coefficient of Variation 39.9
|
63.7 ng*h/mL
Geometric Coefficient of Variation 77.4
|
|
Area Under the Curve (AUC) of ABX464 in Sera
Day 28
|
119.8 ng*h/mL
Geometric Coefficient of Variation 48.7
|
17.8 ng*h/mL
Geometric Coefficient of Variation 60.9
|
30.3 ng*h/mL
Geometric Coefficient of Variation 68.2
|
|
Area Under the Curve (AUC) of ABX464 in Sera
Day 84
|
—
|
—
|
28.9 ng*h/mL
Geometric Coefficient of Variation 66.8
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of ABX464 in Sera
Day 1
|
106.1 ng/mL
Geometric Coefficient of Variation 54.5
|
23.1 ng/mL
Geometric Coefficient of Variation 45.2
|
24.5 ng/mL
Geometric Coefficient of Variation 75.5
|
|
Maximum Observed Concentration (Cmax) of ABX464 in Sera
Day 28
|
50.9 ng/mL
Geometric Coefficient of Variation 57.1
|
9.3 ng/mL
Geometric Coefficient of Variation 60.3
|
13.0 ng/mL
Geometric Coefficient of Variation 76.0
|
|
Maximum Observed Concentration (Cmax) of ABX464 in Sera
Day 84
|
—
|
—
|
15.6 ng/mL
Geometric Coefficient of Variation 65.6
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetics parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Day 1
|
50115.8 ng*h/mL
Geometric Coefficient of Variation 41.5
|
8282.3 ng*h/mL
Geometric Coefficient of Variation 37.0
|
11209.6 ng*h/mL
Geometric Coefficient of Variation 66.5
|
|
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Day 28
|
48605.0 ng*h/mL
Geometric Coefficient of Variation 40.6
|
4800.6 ng*h/mL
Geometric Coefficient of Variation 37.0
|
13308.8 ng*h/mL
Geometric Coefficient of Variation 62.5
|
|
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Day 84
|
—
|
—
|
14588.2 ng*h/mL
Geometric Coefficient of Variation 58.3
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Day 1
|
9918.2 ng/mL
Geometric Coefficient of Variation 33.5
|
1626.8 ng/mL
Geometric Coefficient of Variation 36.9
|
2036.2 ng/mL
Geometric Coefficient of Variation 62.8
|
|
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Day 28
|
7011.1 ng/mL
Geometric Coefficient of Variation 37.5
|
695.9 ng/mL
Geometric Coefficient of Variation 38.6
|
1705.5 ng/mL
Geometric Coefficient of Variation 71.8
|
|
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Day 84
|
—
|
—
|
2150.6 ng/mL
Geometric Coefficient of Variation 56.1
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Day 1
|
463.3 ng/mL
Geometric Coefficient of Variation 55.0
|
209.4 ng/mL
Geometric Coefficient of Variation 54.4
|
203.8 ng/mL
Geometric Coefficient of Variation 81.0
|
|
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Day 28
|
247.8 ng/mL
Geometric Coefficient of Variation 75.7
|
76.4 ng/mL
Geometric Coefficient of Variation 51.7
|
72.3 ng/mL
Geometric Coefficient of Variation 82.9
|
|
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Day 84
|
—
|
—
|
73.6 ng/mL
Geometric Coefficient of Variation 57.5
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Day 1
|
1120.7 ng*h/mL
Geometric Coefficient of Variation 52.6
|
594.2 ng*h/mL
Geometric Coefficient of Variation 53.2
|
481.5 ng*h/mL
Geometric Coefficient of Variation 78.9
|
|
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Day 28
|
522.4 ng*h/mL
Geometric Coefficient of Variation 49.2
|
156.0 ng*h/mL
Geometric Coefficient of Variation 51.8
|
151.6 ng*h/mL
Geometric Coefficient of Variation 74.3
|
|
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Day 84
|
—
|
—
|
144.9 ng*h/mL
Geometric Coefficient of Variation 48.6
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Day 28
|
491.5 ng/mL
Geometric Coefficient of Variation 73.0
|
35.6 ng/mL
Geometric Coefficient of Variation 85.7
|
125.1 ng/mL
Geometric Coefficient of Variation 86.1
|
|
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Day 1
|
585.5 ng/mL
Geometric Coefficient of Variation 60.3
|
39.7 ng/mL
Geometric Coefficient of Variation 90.5
|
230.0 ng/mL
Geometric Coefficient of Variation 153.9
|
|
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Day 84
|
—
|
—
|
153.3 ng/mL
Geometric Coefficient of Variation 49.4
|
PRIMARY outcome
Timeframe: Day 1, Day 28 and Day 84Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Day 1
|
2133.7 ng*h/mL
Geometric Coefficient of Variation 42.2
|
39.2 ng*h/mL
Geometric Coefficient of Variation 186.7
|
835.3 ng*h/mL
Geometric Coefficient of Variation 116.0
|
|
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Day 28
|
2212.3 ng*h/mL
Geometric Coefficient of Variation 58.8
|
35.0 ng*h/mL
Geometric Coefficient of Variation 210.1
|
697.5 ng*h/mL
Geometric Coefficient of Variation 92.0
|
|
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Day 84
|
—
|
—
|
766.5 ng*h/mL
Geometric Coefficient of Variation 57.4
|
PRIMARY outcome
Timeframe: Day 1, Day 28, Day 56, Day 84 and Day 112Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 1
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
|
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 28
|
0.1 ng/mL
Standard Deviation 0.11
|
0.1 ng/mL
Standard Deviation 0.19
|
0.1 ng/mL
Standard Deviation 0.13
|
|
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 56
|
0.0 ng/mL
Standard Deviation 0.00
|
—
|
—
|
|
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 84
|
—
|
—
|
0.1 ng/mL
Standard Deviation 0.13
|
|
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 112
|
—
|
—
|
0.0 ng/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Day 1, Day 28, Day 56, Day 84 and Day 112Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
Pharmacokinetic parameters
Outcome measures
| Measure |
ABX464 150mg
n=11 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 1
|
0.0 ng/mL
Standard Deviation 0.00
|
0.1 ng/mL
Standard Deviation 0.08
|
0.0 ng/mL
Standard Deviation 0.00
|
|
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 28
|
0.1 ng/mL
Standard Deviation 0.04
|
0.1 ng/mL
Standard Deviation 0.11
|
0.1 ng/mL
Standard Deviation 0.09
|
|
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 56
|
0.0 ng/mL
Standard Deviation 0.00
|
—
|
—
|
|
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 84
|
—
|
—
|
0.2 ng/mL
Standard Deviation 0.11
|
|
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Day 112
|
—
|
—
|
0.0 ng/mL
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Day 28, Day 56, Day 84 and Day 112Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. HIV viral measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.
Viral Load Assessments (HIV-1 RNA copies/ml)
Outcome measures
| Measure |
ABX464 150mg
n=9 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=8 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)
Day 28
|
-0.9 copies/mL
Interval -1.9 to 0.1
|
-2.0 copies/mL
Interval -4.3 to 0.2
|
—
|
|
Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)
Day 56
|
-0.4 copies/mL
Interval -1.5 to 0.7
|
—
|
—
|
|
Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)
Day 84
|
—
|
-0.9 copies/mL
Interval -3.0 to 1.2
|
—
|
|
Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)
Day 112
|
—
|
-1.1 copies/mL
Interval -3.7 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Day 28, Day 35, Day 56, Day 84, Day 91 and Day 112Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. CD4+ counts measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.
T-cell determinations
Outcome measures
| Measure |
ABX464 150mg
n=9 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
CD4+ Counts (Cell/mm^3)
Day 28
|
-130.6 cells/mm^3
Interval -217.5 to -43.6
|
-34.6 cells/mm^3
Interval -167.7 to 98.5
|
—
|
|
CD4+ Counts (Cell/mm^3)
Day 35
|
-125.6 cells/mm^3
Interval -266.2 to 15.1
|
—
|
—
|
|
CD4+ Counts (Cell/mm^3)
Day 56
|
29.6 cells/mm^3
Interval -202.4 to 261.5
|
—
|
—
|
|
CD4+ Counts (Cell/mm^3)
Day 84
|
—
|
8.3 cells/mm^3
Interval -90.2 to 106.9
|
—
|
|
CD4+ Counts (Cell/mm^3)
Day 91
|
—
|
23.3 cells/mm^3
Interval -122.5 to 169.0
|
—
|
|
CD4+ Counts (Cell/mm^3)
Day 112
|
—
|
161.8 cells/mm^3
Interval 59.5 to 264.2
|
—
|
SECONDARY outcome
Timeframe: Day 28, Day 56, Day 84 and Day 112Population: Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. Total HIV-1 DNA reservoir measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.
HIV reservoir cells (CD4+)
Outcome measures
| Measure |
ABX464 150mg
n=9 Participants
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 Participants
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)
Day 28
|
-86.8 copies/10^6 cells
Interval -172.2 to -1.3
|
22.3 copies/10^6 cells
Interval -21.7 to 66.4
|
—
|
|
Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)
Day 56
|
-37.1 copies/10^6 cells
Interval -139.1 to 64.9
|
—
|
—
|
|
Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)
Day 84
|
—
|
10.8 copies/10^6 cells
Interval -55.3 to 76.9
|
—
|
|
Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)
Day 112
|
—
|
95.6 copies/10^6 cells
Interval 26.1 to 165.0
|
—
|
Adverse Events
ABX464 150mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
ABX464 50mg for 28 Days
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ABX464 50mg for 84 Days
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABX464 150mg
n=11 participants at risk
ABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
|
ABX464 50mg for 28 Days
n=12 participants at risk
ABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
|
ABX464 50mg for 84 Days
n=13 participants at risk
ABX464, 50mg per Capsule One Capsule per day for 84 days
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
|
|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
7.7%
1/13 • Number of events 2 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 4 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
General disorders
Feeling abnormal
|
0.00%
0/11 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
7.7%
1/13 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
General disorders
Malaise
|
9.1%
1/11 • Number of events 5 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
7.7%
1/13 • Number of events 2 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
General disorders
Thirst
|
0.00%
0/11 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
7.7%
1/13 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
7.7%
1/13 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Psychiatric disorders
Nightmare
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11 • Number of events 3 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
15.4%
2/13 • Number of events 2 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
General disorders
Asthemia
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Metabolism and nutrition disorders
Hyperlipaseamia
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
36.4%
4/11 • Number of events 5 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
7.7%
1/13 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.4%
4/11 • Number of events 4 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Nervous system disorders
Headache
|
72.7%
8/11 • Number of events 9 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
16.7%
2/12 • Number of events 2 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
30.8%
4/13 • Number of events 4 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
8.3%
1/12 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
7.7%
1/13 • Number of events 2 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 2 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/12 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
15.4%
2/13 • Number of events 2 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
8.3%
1/12 • Number of events 1 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
0.00%
0/13 • From baseline up to 112 days
Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60