NCT02990325 is a Phase 1, PHASE2 clinical trial of ABX464 150mg in HIV Infections, sponsored by Abivax S.A..

Who is sponsoring NCT02990325?

NCT02990325 is sponsored by Abivax S.A..

What drugs are being tested in NCT02990325?

Interventions in NCT02990325: ABX464 150mg, ABX464 50mg, ABX464 50mg.

What condition does NCT02990325 study?

NCT02990325 studies HIV Infections, Health Volunteers.

Is NCT02990325 still recruiting?

NCT02990325 is currently completed. Last updated 31 March 2023.

Are results published for NCT02990325?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-31 · How we verify

NCT02990325

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults

Completed Phase 1, PHASE2 Results posted Last updated 31 March 2023

What this trial tests

Phase 1, PHASE2 trial testing ABX464 150mg in HIV Infections in 36 participants. Completed in 21 October 2019.

Timeline

27 March 2017

Primary endpoint
27 December 2018

21 October 2019

Quick facts

Lead sponsor	Abivax S.A.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	27 March 2017
Primary completion	27 December 2018
Estimated completion	21 October 2019
Sites	1 location across Spain

Drugs / interventions tested

ABX464 150mg — full drug profile →
ABX464 50mg — full drug profile →
ABX464 50mg — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →
Health Volunteers — all drugs for Health Volunteers →

Sponsor

Abivax S.A. — full company profile →

Who can join

Adults 18 to 65, male only, with HIV Infections or Health Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Curve (AUC) of ABX464 in Sera Primary · Day 1, Day 28 and Day 84

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	306.0	± 46.5
ABX464 50mg for 28 Days	63.7	± 39.9
ABX464 50mg for 84 Days	63.7	± 77.4

Day 28

Group	Value	95% CI
ABX464 150mg	119.8	± 48.7
ABX464 50mg for 28 Days	17.8	± 60.9
ABX464 50mg for 84 Days	30.3	± 68.2

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	28.9	± 66.8

Maximum Observed Concentration (Cmax) of ABX464 in Sera Primary · Day 1, Day 28 and day 84

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	106.1	± 54.5
ABX464 50mg for 28 Days	23.1	± 45.2
ABX464 50mg for 84 Days	24.5	± 75.5

Day 28

Group	Value	95% CI
ABX464 150mg	50.9	± 57.1
ABX464 50mg for 28 Days	9.3	± 60.3
ABX464 50mg for 84 Days	13.0	± 76.0

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	15.6	± 65.6

Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera Primary · Day 1, Day 28 and Day 84

Pharmacokinetics parameters

Day 1

Group	Value	95% CI
ABX461 150mg	50115.8	± 41.5
ABX464 50mg for 28 Days	8282.3	± 37.0
ABX464 50mg for 84 Days	11209.6	± 66.5

Day 28

Group	Value	95% CI
ABX461 150mg	48605.0	± 40.6
ABX464 50mg for 28 Days	4800.6	± 37.0
ABX464 50mg for 84 Days	13308.8	± 62.5

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	14588.2	± 58.3

Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera Primary · Day 1, Day 28 and Day 84

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	9918.2	± 33.5
ABX464 50mg for 28 Days	1626.8	± 36.9
ABX464 50mg for 84 Days	2036.2	± 62.8

Day 28

Group	Value	95% CI
ABX464 150mg	7011.1	± 37.5
ABX464 50mg for 28 Days	695.9	± 38.6
ABX464 50mg for 84 Days	1705.5	± 71.8

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	2150.6	± 56.1

Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC) Primary · Day 1, Day 28 and Day 84

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	463.3	± 55.0
ABX464 50mg for 28 Days	209.4	± 54.4
ABX464 50mg for 84 Days	203.8	± 81.0

Day 28

Group	Value	95% CI
ABX464 150mg	247.8	± 75.7
ABX464 50mg for 28 Days	76.4	± 51.7
ABX464 50mg for 84 Days	72.3	± 82.9

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	73.6	± 57.5

Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC) Primary · Day 1, Day 28 and Day 84

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	1120.7	± 52.6
ABX464 50mg for 28 Days	594.2	± 53.2
ABX464 50mg for 84 Days	481.5	± 78.9

Day 28

Group	Value	95% CI
ABX464 150mg	522.4	± 49.2
ABX464 50mg for 28 Days	156.0	± 51.8
ABX464 50mg for 84 Days	151.6	± 74.3

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	144.9	± 48.6

Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC) Primary · Day 1, Day 28 and Day 84

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	585.5	± 60.3
ABX464 50mg for 28 Days	39.7	± 90.5
ABX464 50mg for 84 Days	230.0	± 153.9

Day 28

Group	Value	95% CI
ABX464 150mg	491.5	± 73.0
ABX464 50mg for 28 Days	35.6	± 85.7
ABX464 50mg for 84 Days	125.1	± 86.1

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	153.3	± 49.4

Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC) Primary · Day 1, Day 28 and Day 84

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	2133.7	± 42.2
ABX464 50mg for 28 Days	39.2	± 186.7
ABX464 50mg for 84 Days	835.3	± 116.0

Day 28

Group	Value	95% CI
ABX464 150mg	2212.3	± 58.8
ABX464 50mg for 28 Days	35.0	± 210.1
ABX464 50mg for 84 Days	697.5	± 92.0

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	766.5	± 57.4

Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint) Primary · Day 1, Day 28, Day 56, Day 84 and Day 112

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	0.0	± 0.00
ABX464 50mg for 28 Days	0.0	± 0.00
ABX464 50mg for 84 Days	0.0	± 0.00

Day 28

Group	Value	95% CI
ABX464 150mg	0.1	± 0.11
ABX464 50mg for 28 Days	0.1	± 0.19
ABX464 50mg for 84 Days	0.1	± 0.13

Day 56

Group	Value	95% CI
ABX464 150mg	0.0	± 0.00

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	0.1	± 0.13

Day 112

Group	Value	95% CI
ABX464 50mg for 84 Days	0.0	± 0.00

Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint) Primary · Day 1, Day 28, Day 56, Day 84 and Day 112

Pharmacokinetic parameters

Day 1

Group	Value	95% CI
ABX464 150mg	0.0	± 0.00
ABX464 50mg for 28 Days	0.1	± 0.08
ABX464 50mg for 84 Days	0.0	± 0.00

Day 28

Group	Value	95% CI
ABX464 150mg	0.1	± 0.04
ABX464 50mg for 28 Days	0.1	± 0.11
ABX464 50mg for 84 Days	0.1	± 0.09

Day 56

Group	Value	95% CI
ABX464 150mg	0.0	± 0.00

Day 84

Group	Value	95% CI
ABX464 50mg for 84 Days	0.2	± 0.11

Day 112

Group	Value	95% CI
ABX464 50mg for 84 Days	0.0	± 0.00

Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay) Secondary · Day 28, Day 56, Day 84 and Day 112

Viral Load Assessments (HIV-1 RNA copies/ml)

Day 28

Group	Value	95% CI
ABX464 150mg	-0.9	-1.9 – 0.1
ABX464 50mg	-2.0	-4.3 – 0.2

Day 56

Group	Value	95% CI
ABX464 150mg	-0.4	-1.5 – 0.7

Day 84

Group	Value	95% CI
ABX464 50mg	-0.9	-3.0 – 1.2

Day 112

Group	Value	95% CI
ABX464 50mg	-1.1	-3.7 – 1.5

CD4+ Counts (Cell/mm^3) Secondary · Day 28, Day 35, Day 56, Day 84, Day 91 and Day 112

T-cell determinations

Day 28

Group	Value	95% CI
ABX464 150mg	-130.6	-217.5 – -43.6
ABX464 50mg	-34.6	-167.7 – 98.5

Day 35

Group	Value	95% CI
ABX464 150mg	-125.6	-266.2 – 15.1

Day 56

Group	Value	95% CI
ABX464 150mg	29.6	-202.4 – 261.5

Day 84

Group	Value	95% CI
ABX464 50mg	8.3	-90.2 – 106.9

Day 91

Group	Value	95% CI
ABX464 50mg	23.3	-122.5 – 169.0

Day 112

Group	Value	95% CI
ABX464 50mg	161.8	59.5 – 264.2

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline up to 112 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ABX464 150mg

Serious: 0/11 (0%)

Deaths: 0/11

ABX464 50mg for 28 Days

Serious: 0/12 (0%)

Deaths: 0/12

ABX464 50mg for 84 Days

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (25 terms — click to expand)

Reaction	System	ABX464 150mg	ABX464 50mg for 28 Days	ABX464 50mg for 84 Days
Headache	Nervous system disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Asthemia	General disorders	—	—	—
Hyperamylasaemia	Metabolism and nutrition disorders	—	—	—
Hyperlipaseamia	Metabolism and nutrition disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Chest pain	General disorders	—	—	—
Feeling abnormal	General disorders	—	—	—
Malaise	General disorders	—	—	—
Thirst	General disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Migraine	Nervous system disorders	—	—	—
Nightmare	Psychiatric disorders	—	—	—
Folliculitis	Skin and subcutaneous tissue disorders	—	—	—
Rash erythematous	Skin and subcutaneous tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT02990325 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Innovation and trends in the development and approval of antiviral medicines: 1987-2017 and beyond.
Chaudhuri S, Symons JA, Deval J. · · 2018 · cited 136× · PMID 29758235 · DOI 10.1016/j.antiviral.2018.05.005
Strategies to Modulate MicroRNA Functions for the Treatment of Cancer or Organ Injury.
Lee TJ, Yuan X, Kerr K, Yoo JY, et al · · 2020 · cited 55× · PMID 32554488 · DOI 10.1124/pr.119.019026
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.
Moron-Lopez S, Bernal S, Wong JK, Martinez-Picado J, et al · · 2022 · cited 13× · PMID 34436569 · DOI 10.1093/cid/ciab733
MicroRNAs in T Cell-Immunotherapy.
Dosil SG, Rodríguez-Galán A, Sánchez-Madrid F, Fernández-Messina L. · · 2022 · cited 10× · PMID 36613706 · DOI 10.3390/ijms24010250
Non-nucleoside structured compounds with antiviral activity-past 10 years (2010-2020).
Denel-Bobrowska M, Olejniczak AB. · · 2022 · cited 5× · PMID 35085926 · DOI 10.1016/j.ejmech.2022.114136
Impact of Obefazimod on Viral Persistence, Inflammation, and Immune Activation in People With Human Immunodeficiency Virus on Suppressive Antiretroviral Therapy.
Bernal S, Puertas MC, Morón-López S, Cranston RD, et al · · 2023 · cited 4× · PMID 37395474 · DOI 10.1093/infdis/jiad251
Development and characterization of a double-fluorescent HIV-1 reporter cellular model to tackle the Rev-dependent export pathway.
Wadas J, Ali H, Osiecka A, Dorman A, et al · · 2025 · PMID 39902983 · DOI 10.1128/spectrum.01903-24
Abstracts of the 9th HIV Persistence During Therapy Workshop : 10–13 December 2019, Miami, Florida, USA

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other Abivax S.A. trials

Trials by the same sponsor.

NCT05507216 — ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 · Phase 3 · completed
NCT05507203 — ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 · Phase 3 · completed
NCT03905109 — Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients · Phase 2, PHASE3 · withdrawn
NCT05032560 — Safety and Pharmacokinetics Study in Healthy Japanese Volunteers · Phase 1 · completed
NCT05121714 — Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02990325 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abivax S.A.
Last refreshed: 31 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02990325.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02990325

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for HIV Infections

Other Abivax S.A. trials

Verify against primary sources