HIV InfectionsPhase 1/2NCT02990325

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

A Phase 1/2 study testing ABX464 150mg and ABX464 50mg in people with HIV Infections and Health Volunteers, run by Abivax S.A. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections, Health Volunteers
What is being tested?: ABX464 150mg and ABX464 50mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSpain
Study dates: 27 Mar 2017to 21 Oct 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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;

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916

Other trials in Spain

About this study

Official title: An Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX464 in HIV-1 Seronegative and Seropositive Adults

Read the detailed 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. 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.

Conditions: HIV Infections, Health Volunteers
Being tested: ABX464 150mg, ABX464 50mg
Keywords: ABX464, HIV infection
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABX464 150mgDrug
ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
ABX464 50mgDrug
ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
ABX464 50mgDrug
ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)

Study groups in NCT02990325
Study group	Role	What they receive
ABX464 150mg	Experimental	ABX464, 50mg per Capsule Three Capsules per day for 28 days Receives: Drug: ABX464 150mg
ABX464 50mg for 28 days	Experimental	ABX464, 50mg per Capsule One Capsule per day for 28 days Receives: Drug: ABX464 50mg
ABX464 50mg for 84 days	Experimental	ABX464, 50mg per Capsule One Capsule per day for 84 days Receives: Drug: ABX464 50mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve (AUC) of ABX464 in Sera
Pharmacokinetic parameters
Measured: Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 in Sera
Pharmacokinetic parameters
Measured: Day 1, Day 28 and day 84
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Pharmacokinetics parameters
Measured: Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Pharmacokinetic parameters
Measured: Day 1, Day 28 and Day 84
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Pharmacokinetic parameters
Measured: Day 1, Day 28 and Day 84
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Pharmacokinetic parameters
Measured: 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
Measured: 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
Measured: Day 1, Day 28 and Day 84
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Pharmacokinetic parameters
Measured: 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
Measured: Day 1, Day 28, Day 56, Day 84 and Day 112

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201721 Oct 2019

First posted13 Dec 2016 (estimated)
Study start27 Mar 2017
Primary completion27 Dec 2018
Study completion21 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02990325
Sponsor's protocol ID: ABX464-005
Status last verified: Mar 2023
First submitted: 7 Dec 2016
Last updated: 31 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34436569

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX464 in HIV-1 Seronegative and Seropositive Adults
ClinicalTrials.gov ID: NCT02990325
Acronym / sponsor ID: ABX464-005
Conditions: HIV Infections, Health Volunteers
Keywords: ABX464, HIV infection
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Abivax S.A.Industry (pharma, biotech, devices)
Study start: 27 Mar 2017 (actual)
Primary completion: 27 Dec 2018 (actual)
Study completion: 21 Oct 2019 (actual)
First posted: 13 Dec 2016 (estimated)
Results: Posted 31 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ABX464 150mg	Experimental	Drug: ABX464 150mgABX464, 50mg per Capsule Three Capsules per day for 28 days
ABX464 50mg for 28 days	Experimental	Drug: ABX464 50mgABX464, 50mg per Capsule One Capsule per day for 28 days
ABX464 50mg for 84 days	Experimental	Drug: ABX464 50mgABX464, 50mg per Capsule One Capsule per day for 84 days

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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).

Key exclusion criteria (5 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABX464 150mgABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)	Drug	ABX464 150mg
ABX464 50mgABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)	Drug	ABX464 50mg for 28 days
ABX464 50mgABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)	Drug	ABX464 50mg for 84 days

Primary outcome

Area Under the Curve (AUC) of ABX464 in Sera
Time frame: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Maximum Observed Concentration (Cmax) of ABX464 in Sera
Time frame: Day 1, Day 28 and day 84
Pharmacokinetic parameters
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Time frame: Day 1, Day 28 and Day 84
Pharmacokinetics parameters
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
Time frame: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Time frame: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
Time frame: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Time frame: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
Time frame: Day 1, Day 28 and Day 84
Pharmacokinetic parameters
Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Time frame: Day 1, Day 28, Day 56, Day 84 and Day 112
Pharmacokinetic parameters
Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
Time frame: Day 1, Day 28, Day 56, Day 84 and Day 112
Pharmacokinetic parameters

3 secondary outcomes

Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)
Time frame: Day 28, Day 56, Day 84 and Day 112
CD4+ Counts (Cell/mm^3)
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)
Time frame: Day 28, Day 56, Day 84 and Day 112

Results and safety

Results posted to the registry on 31 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABX464 150mg	11	11
ABX464 50mg for 28 Days	12	12
ABX464 50mg for 84 Days	13	13

Primary outcome: Area Under the Curve (AUC) of ABX464 in Sera

Time frame: Day 1, Day 28 and Day 84. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	ABX464 150mg n = 11	ABX464 50mg for 28 Days n = 12	ABX464 50mg for 84 Days n = 13
Day 1	306.0 (46.5)	63.7 (39.9)	63.7 (77.4)
Day 28	119.8 (48.7)	17.8 (60.9)	30.3 (68.2)
Day 84	–	–	28.9 (66.8)

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

Primary outcome: Maximum Observed Concentration (Cmax) of ABX464 in Sera

Time frame: Day 1, Day 28 and day 84. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	ABX464 150mg n = 11	ABX464 50mg for 28 Days n = 12	ABX464 50mg for 84 Days n = 13
Day 1	106.1 (54.5)	23.1 (45.2)	24.5 (75.5)
Day 28	50.9 (57.1)	9.3 (60.3)	13.0 (76.0)
Day 84	–	–	15.6 (65.6)

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

Primary outcome: Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera

Time frame: Day 1, Day 28 and Day 84. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	ABX461 150mg n = 11	ABX464 50mg for 28 Days n = 12	ABX464 50mg for 84 Days n = 13
Day 1	50115.8 (41.5)	8282.3 (37.0)	11209.6 (66.5)
Day 28	48605.0 (40.6)	4800.6 (37.0)	13308.8 (62.5)
Day 84	–	–	14588.2 (58.3)

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

Primary outcome: Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera

Time frame: Day 1, Day 28 and Day 84. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	ABX464 150mg n = 11	ABX464 50mg for 28 Days n = 12	ABX464 50mg for 84 Days n = 13
Day 1	9918.2 (33.5)	1626.8 (36.9)	2036.2 (62.8)
Day 28	7011.1 (37.5)	695.9 (38.6)	1705.5 (71.8)
Day 84	–	–	2150.6 (56.1)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 112 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABX464 150mg	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11
ABX464 50mg for 28 Days	0 of 12 (0%)	3 of 12 (25%)	0 of 12
ABX464 50mg for 84 Days	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34436569Moron-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul GINESTE, PhD study director

Abivax S.A.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABX464 150mg and ABX464 50mg in people with HIV Infections and Health Volunteers, run by Abivax S.A. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve (AUC) of ABX464 in Sera (time frame: Day 1, Day 28 and Day 84). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02990325, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.