A Safety, Pharmacokinetics, and Pharmacodynamics Study of... | NCT02990325

NCT02990325

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABX464 150mg	Experimental	ABX464, 50mg per Capsule Three Capsules per day for 28 days	Drug: ABX464 150mg
ABX464 50mg for 28 days	Experimental	ABX464, 50mg per Capsule One Capsule per day for 28 days	Drug: ABX464 50mg
ABX464 50mg for 84 days	Experimental	ABX464, 50mg per Capsule One Capsule per day for 84 days	Drug: ABX464 50mg

Name	Type	Description	Arm Group Labels	Other Names
ABX464 150mg	Drug	ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)	ABX464 150mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Curve (AUC) of ABX464 in Sera	Pharmacokinetic parameters	Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 in Sera	Pharmacokinetic parameters	Day 1, Day 28 and day 84
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera	Pharmacokinetics parameters	Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera	Pharmacokinetic parameters	Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)	Pharmacokinetic parameters	Day 1, Day 28 and Day 84
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)	Pharmacokinetic parameters	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	Day 1, Day 28 and Day 84
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)	Viral Load Assessments (HIV-1 RNA copies/ml)	Day 28, Day 56, Day 84 and Day 112
CD4+ Counts (Cell/mm^3)	T-cell determinations

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Males aged 18-65 years;
Subjects with adequate hematological and biochemical laboratory parameters
Subjects should be able and willing to comply with study visits and procedures as per protocol;
Subjects should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;
Subjects must agree to use in addition to the condom, a second highly effective method (one for the subject and one for the partner) of contraception (defined as per the Clinical Trials Facilitation and Coordination Group (CTFG) Guidance).

For HIV positive Subjects

Subjects with a positive HIV-1 serology at any time before the study entry.
Subjects treated for at least 12 months prior to screening with Dolutegravir or Raltegravir combined with either Tenofovir + Emtricitabine (TDF/FTC) or Abacavir + Lamivudine (ABC/3TC);
Subjects with HIV plasma viral load ≤ 50 copies/mL during the 6 months prior to screening with a maximum of 2 blips ≤ 1000 copies during this period;
Subjects' HIV-1 plasma viral load to be ≤ 100,000 copies/mL at any time beyond 6 months after the estimated date of primary infection;

Exclusion Criteria:

History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of investigational products;
Acute or chronic infectious disease other than HIV infection (include but not limited to viral hepatitis such as hepatitis B, hepatitis C, active tuberculosis, active syphilis [i.e. currently treated].
Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (CNS) pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
Severe hepatic impairment;
Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;

Name	Affiliation	Role
Paul GINESTE, PhD	Abivax S.A.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Germans Trias i Pujol		Badalona	Catalonia	08916	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34436569	Derived	Moron-Lopez S, Bernal S, Wong JK, Martinez-Picado J, Yukl SA. ABX464 Decreases the Total Human Immunodeficiency Virus (HIV) Reservoir and HIV Transcription Initiation in CD4+ T Cells From Antiretroviral Therapy-Suppressed Individuals Living With HIV. Clin Infect Dis. 2022 Jun 10;74(11):2044-2049. doi: 10.1093/cid/ciab733.

Arm/Group Information

ID	Title	Description
FG000	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)
FG001	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)
FG002	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)

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	ABX464 150 mg Capsules for 28 Days	ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
BG001	ABX464 50 mg Capsules for 28 Days

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Curve (AUC) of ABX464 in Sera

Pharmacokinetic parameters

Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

Day 1, Day 28 and Day 84

ID	Title	Description
OG000	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)
OG001	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)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 4, 2018	May 31, 2022	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Apr 29, 2019	May 31, 2022	SAP_001.pdf

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral