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

NCT02735863 | Completed Phase 2 Results DMC

• 1 other identifier: ABX464-004
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 8

Brief 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).

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 4 months

Secondary Outcomes (1)

• Time to Viral Rebound

  Up to 3 months

Study Arms (2)

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)

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)

Drug: Placebo

Interventions

ABX464 DRUG

50 mg or 150mg once daily for 28 days

ABX464

Placebo DRUG

ABX464 matching placebo

ABX464 Matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (8)

C.H.U. Saint-Pierre

Brussels, 1000, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

CHU Sart Tilman

Liège, 4000, Belgium

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, 34 295, France

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitari Germans Trias i Pujo

Barcelona, 08916, Spain

Location

Related Publications (1)

• 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.

  PMID: 30800421 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

ABX464

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Sharon Skare
• Organization: ABIVAX

sharon.skare@abivax.com

+33153830961

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 13, 2016
• Study Start: May 1, 2016
• Primary Completion: August 30, 2017
• Study Completion: January 11, 2018
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2022-06

Locations

FR (2); BE (3); ES (3)