Clinical Trials Register

Summary
EudraCT Number:	2015-004195-30
Sponsor's Protocol Code Number:	ABX464-004
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-12-14
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2015-004195-30

A.3

Full title of the trial

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).

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Safety study of ABX464 in HIV controlled patients treated with boosted protease inhibitor treatment.

A.4.1

Sponsor's protocol code number

ABX464-004

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Abivax
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Abivax
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Abivax
B.5.2	Functional name of contact point	Head of Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	5 rue de la Baume
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75008
B.5.3.4	Country	France
B.5.4	Telephone number	+ 33 (0) 1 53 83 09 61
B.5.6	E-mail	Paul.Gineste@abivax.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ABX464
D.3.2	Product code	ABX464
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABX464
D.3.9.2	Current sponsor code	ABX464
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ABX464
D.3.9.2	Current sponsor code	ABX464
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Human Immunodeficiency Virus (HIV)

E.1.1.1

Medical condition in easily understood language

Chronic viral infection

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10020443
E.1.2	Term	Human immunodeficiency virus syndrome
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety of ABX464 versus placebo when administered on top of darunavir/ritonavir or darunavir/cobicistat monotherapy.

E.2.2

Secondary objectives of the trial

- To evaluate the long-lasting effect of ABX464 on the viral load after treatment stop
(i.e. Day 29)using the Time to Viral Rebound versus placebo;
- To compare the viral load (HIV RNA) versus placebo from Day 0 to Viral Rebound
- To compare the CD4+ T cell counts versus placebo from Day 0 to Viral Rebound;
- To compare the CD4+/CD8+ T cells ratio versus placebo from Day 0 to Viral Rebound;
- To evaluate HIV reservoir (pro-viral DNA in PBMC) versus placebo from Day 0 to Viral Rebound.
- To assess the Pharmacokinetics parameters of ABX464 given on top of darunavir/ritonavir/cobicistat and ABX464;
- To compare miRNA modulations and tropism of HIV versus placebo from Day 0 to Viral Rebound

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- 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;
- Patients with hematological and biochemical laboratory parameters as follows and within 7 days of baseline:
o Hemoglobin > 9.0 g dL-1;
o Absolute neutrophil count ≥ 750 mm-3;
o Platelets ≥ 100,000 mm-3;
o Total serum creatinine ≤ 1.3 x ULN (upper limit of normal);
o Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation within 60 days of entry;
o Total serum bilirubin < 2.0 x ULN;
o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x ULN;
o Serum lipase less than or equal to 2.0 x ULN;
- Patients should be able and willing to comply with study visits and procedures as per protocol;
- Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;
- Patients should be affiliated to a social security regimen (for French sites only);
- Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 2 weeks prior to study participation. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception associated with inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle.

E.4

Principal exclusion criteria

- 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;
- History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of the study drug;
- Acute or chronic infectious disease other than HIV infection (include but not limited to viral hepatitis such as hepatitis B, active tuberculosis, active syphilis [i.e. currently treated], HTLV-1, HTLV-2). Of note co-infection with hepatitis C is allowed as long as their liver function parameters are within the following ranges: platelet > 150.000/mm3; γGT ≤ 2.5 ULN; Albumin > 40 g/L and providing that they are not receiving specific treatment during the study that could interfere with the study objectives;
- Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable 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;
- uncontrolled dyslipidemia;
- Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
- Unstable asthma (defined as sudden acute attacks occurring in less than three hours without an obvious trigger, hospitalization for asthma in the last two years); food or wine induced asthma;
- History of malignancy unless there has been surgical excision that is considered to have achieved cure;
- Active malignancy that may require chemotherapy or radiation therapy;
- Seizure disorder or any history of prior seizure;
- Serious illness requiring systemic treatment and/or hospitalization within 7 days prior to baseline;
- Pregnant or breast-feeding woman;
- Active drug or alcohol abuse or dependence;
- Use of any investigational or non-registered product within 3 months preceding baseline;
- Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

E.5 End points

E.5.1

Primary end point(s)

Safety (Adverse events)

E.5.1.1

Timepoint(s) of evaluation of this end point

Timepoint(s) of evaluation of this end point from Day 0 to EoS

E.5.2

Secondary end point(s)

1. Time to Virological Failure
2. Time to Treatment Failure
3. Viral load
4. CD4+ T cell counts
5. CD4+/CD8+ T cells ratio
6. HIV Reservoirs
7. PK parameters

E.5.2.1

Timepoint(s) of evaluation of this end point

1. After D28 (kaplan Meier)
2. After D28 (kaplan Meier)
3. From Day 0 to EoS
4. From Day 0 to EoS
5. From Day 0 to EoS
6. From Day 0 to EoS
7. According to PK time points

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Normal standard of care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-05-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-08-30

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