Human Immunodeficiency Virus (HIV) MedDRA version: 19.0 Level: LLT Classification code 10020443 Term: Human immunodeficiency virus syndrome System Organ Class: 100000004862
Conditions
Interventions
Product Name: ABX464
Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Abivax
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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; ?GT = 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of ABX464 versus placebo when administered on top of darunavir/ritonavir or darunavir/cobicistat monotherapy.;Secondary Objective: - 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;Primary end point(s): Safety (Adverse events);Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of this end point from Day 0 to EoS | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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 | — |
Countries
Belgium, Spain
Contacts
Public ContactHead of Clinical Operations
Abivax
Outcome results
None listed