ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment

A Phase 2 study testing ABX464 in people with HIV Infection, run by Abivax S.A. at 8 sites in 3 countries.

Completed

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

Trial summary

This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are treated with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV Infection
What is being tested?: ABX464
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 8 sitesin 3 countries
Study dates: May 2016to 11 Jan 2018
Phase: Phase 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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients infected with HIV;
Patients with HIV plasma viral load ≤ 50 copies mL-1 during the 6 months prior to screening with a maximum of 2 blips during this period;
Patients treated by DRV/RTV or DRV/COBI as a monotherapy for at least 8 weeks prior to baseline;
Patients' HIV plasma viral load ≤100,000 copies mL-1 at any time (apart from primary infection if recorded);
Patients' CD4+ T cells count ≥ 250 cells per mm3 at any time since diagnosis;
Patients with CD4+ T cells count ≥ 600 cells per mm3 at screening;
Man or woman aged 18-65 years;

Who cannot join

Patient displaying any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);
Patient having had previously a viral load ≥ 500 copies mL-1 confirmed by a second measure since the initiation of the current ART;
History of an AIDS-defining clinical illness;
Concomitant AIDS-related opportunistic infection;

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Belgium3 sites

C.H.U. Saint-Pierre
Brussels, 1000
Ghent University Hospital
Ghent, 9000
CHU Sart Tilman
Liège, 4000

Other trials in Belgium

Spain3 sites

Hospital Clinic
Barcelona, 08036
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Universitari Germans Trias i Pujo
Barcelona, 08916

Other trials in Spain

France2 sites

Hôpital de la Croix Rousse
Lyon, 69004
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34 295

Other trials in France

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Compare the Safety of ABX464 Given at a Fixed Dose to Placebo in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment (Darunavir/Ritonavir or Darunavir/Cobicistat).

Read the detailed description

This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered at 50 mg o.d. and 150 mg versus placebo in HIV infected patients who are treated with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI). Eligible patients should be treated with darunavir + ritonavir or darunavir + cobicistat as monotherapy for at least 8 weeks prior to baseline. Patients should be fully suppressed (< 50 copies/mL) at least during the last 6 months prior to enrolment.

Upon screening visit, eligible patients will continue DRV/RTV or DRV/COBI single regimen given respectively at 800 mg of darunavir with 100 mg of ritonavir or 150 mg of cobicistat once a day with food in the morning.

At Day 0, study drug (ABX464 or its matching placebo) will be added on top of this background therapy for the next 28 days. ABX464 or its matching placebo will be given once a day at 50 mg or 150 mg.

At day 29, DRV/RTV or DRV/COBI and ABX464 or its matching placebo (i.e. all treatments) will be stopped. The viral load will be monitored twice a week during the first three weeks and weekly during the next weeks. In case of Viral Rebound (VR; defined below), ART will be resumed.

A 3:1 randomization ratio will be applied meaning that, per treatment block, 3 patients will receive ABX464 on top of DRV/RTV or DRV/COBI and 1 patient will receive placebo on top of DRV/RTV or DRV/COBI.

Dose limiting toxicity (DLT) is defined as a grade 3 or higher adverse event as defined by the "Division of AIDS table for grading the severity of adult and pediatric adverse events" (including signs/symptoms, lab toxicities and/or clinical events) considered by the Data Safety Monitoring Board as probably or definitely related to study treatment.

If more than 2 DLTs occur during the treatment period of the first four treated patients, then the enrolment of additional patients will be stopped. In addition, in case of a life threatening (grade 4) adverse reaction enrolment and treatment of ongoing patients will be immediately discontinued. In both cases, enrolment will only be resumed upon the decision of the sponsor if the Data Safety Monitoring Board can conclude that the causality of the event was unrelated or unlikely related to study treatment.

Thorough pharmacokinetics analysis will be performed to characterize potential drug-drug interactions between ABX464 and DRV/RTV-COBI.

Conditions: HIV Infection
Being tested: ABX464, Placebo
Medical subject headings: HIV Infections

What participants receive

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

ABX464Drug
50 mg or 150mg once daily for 28 days
PlaceboDrug
ABX464 matching placebo

Study groups in NCT02735863
Study group	Role	What they receive
ABX464	Experimental	Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Receives: Drug: ABX464
ABX464 Matching placebo	Placebo comparator	Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) Receives: Drug: Placebo

What is being measured

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

Number of Participants With Adverse Events
Patients who had received at least one dose of the study drug, and who had at least one baseline value. An AE was classified as a TEAE if it started, or increased in severity, on or after the first date and time of medication dosing (from Day 1 up to Day 28). Any AE which occurred after Day 28 was classified as post-treatment-emergent. Events were graded according to the "Division of AIDS table for grading the severity of adult and pediatric adverse events" (Version 2.0 November 2014).
Measured: Up to 4 months

Secondary outcomes (1)

Time to Viral Rebound
Time To Viral Rebound is defined as the time between treatment stop (i.e. day 29) and viral rebound detection
Measured: Up to 3 months

Timeline

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

May 201611 Jan 2018

First posted13 Apr 2016 (estimated)
Study startMay 2016
Primary completion30 Aug 2017
Study completion11 Jan 2018

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 InfectionStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02735863
Sponsor's protocol ID: ABX464-004
Status last verified: Jun 2022
First submitted: 8 Apr 2016
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rutsaert S, Steens JM, Gineste P, Cole B, Kint S, Barrett PN, Tazi J, Scherrer D, Ehrlich HJ, Vandekerckhove L. Safety, tolerability and impact on viral reservoirs of the addition to antiretroviral therapy of ABX464, an investigational antiviral drug, in individuals living with HIV-1: a Phase IIa randomised controlled study. J Virus Erad. 2019 Jan 1;5(1):10-22. doi: 10.1016/S2055-6640(20)30273-9.
PubMed 30800421

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Compare the Safety of ABX464 Given at a Fixed Dose to Placebo in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment (Darunavir/Ritonavir or Darunavir/Cobicistat).
ClinicalTrials.gov ID: NCT02735863
Acronym / sponsor ID: ABX464-004
Conditions: HIV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Abivax S.A.Industry (pharma, biotech, devices)
Study start: May 2016
Primary completion: 30 Aug 2017 (actual)
Study completion: 11 Jan 2018 (actual)
First posted: 13 Apr 2016 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

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

Detailed description

At Day 0, study drug (ABX464 or its matching placebo) will be added on top of this background therapy for the next 28 days. ABX464 or its matching placebo will be given once a day at 50 mg or 150 mg.

Thorough pharmacokinetics analysis will be performed to characterize potential drug-drug interactions between ABX464 and DRV/RTV-COBI.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ABX464	Experimental	Drug: ABX464Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)
ABX464 Matching placebo	Placebo comparator	Drug: PlaceboMatching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients infected with HIV;
Patients with HIV plasma viral load ≤ 50 copies mL-1 during the 6 months prior to screening with a maximum of 2 blips during this period;
Patients treated by DRV/RTV or DRV/COBI as a monotherapy for at least 8 weeks prior to baseline;
Patients' HIV plasma viral load ≤100,000 copies mL-1 at any time (apart from primary infection if recorded);
Patients' CD4+ T cells count ≥ 250 cells per mm3 at any time since diagnosis;

Key exclusion criteria (4 listed)

Patient displaying any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);
Patient having had previously a viral load ≥ 500 copies mL-1 confirmed by a second measure since the initiation of the current ART;
History of an AIDS-defining clinical illness;
Concomitant AIDS-related opportunistic 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
ABX46450 mg or 150mg once daily for 28 days	Drug	ABX464
PlaceboABX464 matching placebo	Drug	ABX464 Matching placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: Up to 4 months
Patients who had received at least one dose of the study drug, and who had at least one baseline value. An AE was classified as a TEAE if it started, or increased in severity, on or after the first date and time of medication dosing (from Day 1 up to Day 28). Any AE which occurred after Day 28 was classified as post-treatment-emergent. Events were graded according to the "Division of AIDS table for grading the severity of adult and pediatric adverse events" (Version 2.0 November 2014).

1 secondary outcome

Time to Viral Rebound
Time frame: Up to 3 months

Results and safety

Results posted to the registry on 19 Sep 2024, 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 50mg	6	5
ABX464 150mg	16	14
ABX464 Matching Placebo	8	7

Primary outcome: Number of Participants With Adverse Events

Time frame: Up to 4 months. Count of participants. Unit: Participants

Measure	ABX464 50mg n = 6	ABX464 150mg n = 16	ABX464 Matching Placebo n = 8
Any AE	5	15	7
Any TEAE	4	15	3
Any post-TEAE	4	6	4
Any serious AE	0	0	1
Any severe AE	0	1	0
AE leading to death	0	0	0

Population analysed: Patients who had received at least one dose of the study drug, and who had at least one baseline value.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABX464 50mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
ABX464 150mg	1 of 16 (6.3%)	15 of 16 (93.8%)	0 of 16
ABX464 Matching Placebo	1 of 8 (12.5%)	7 of 8 (87.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30800421Rutsaert S, Steens JM, Gineste P, Cole B, Kint S, Barrett PN, Tazi J, Scherrer D, Ehrlich HJ, Vandekerckhove L. Safety, tolerability and impact on viral reservoirs of the addition to antiretroviral therapy of ABX464, an investigational antiviral drug, in individuals living with HIV-1: a Phase IIa randomised controlled study. J Virus Erad. 2019 Jan 1;5(1):10-22. doi: 10.1016/S2055-6640(20)30273-9.

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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.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABX464 in people with HIV Infection, run by Abivax S.A. at 8 sites in 3 countries.

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 7 inclusion and 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Belgium, Spain, France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 19 Sep 2024). 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?

Number of Participants With Adverse Events (time frame: Up to 4 months). 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 NCT02735863, 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 19 Sep 2024.