Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Abivax S.A.


Information provided by (Responsible Party)
Abivax S.A.
ClinicalTrials.gov Identifier
NCT02990325

First received: December 7, 2016
Last updated: January 22, 2019
Last Verified: December 2018
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections
Health Volunteers

Drug : ABX464 150mg
Drug : ABX464 50mg
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX464 in HIV-1 Seronegative and Seropositive Adults

Further study details as provided by Abivax S.A.:

Primary Outcome Measures

  • Area Under the Curve (AUC) of ABX464 and its main Metabolite in sera and in rectal tissue [ Time Frame: Up to 112 days after first study treatment administration ]
    Pharmacokinetic parameters
Secondary Outcome Measures:
  • HIV-1 RNA copies/ml [ Time Frame: Up to 112 days after first study treatment administration ]
    Viral Load Assessments
  • CD4+ and CD8+ counts (Cell/mm3) [ Time Frame: Up to 112 days after first study treatment administration ]
    T-cell determinations
  • Total HIV-1 DNA reservoir in PBMC and rectal tissue [ Time Frame: Up to 112 days after first study treatment administration ]
    HIV reservoir cells
  • Microbiota characterization using deep sequencing [ Time Frame: Up to 112 days after first study treatment administration ]
    Microbiota
  • Activation markers in cellular populations (CD3, CD8, CD4, CD45RA, CCR7, CD27, CD28, CD38, HLA-DR, PD-1) [ Time Frame: Up to 112 days after first study treatment administration ]
    T-cell function determinations
  • Number of participants with treatment-related adverse events [ Time Frame: Up to 112 days after first study treatment administration ]
    Safety

Enrollment: 36
Study Start Date: March 17, 2017
Study Completion Date: December 31, 2018
Primary Completion Date: December 1, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: ABX464 150mg
ABX464, 50mg per Capsule Three Capsules per day for 28 days
Drug: ABX464 150mg

ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)

Experimental: ABX464 50mg
ABX464, 50mg per Capsule One Capsule per day for 28 or 84 days
Drug: ABX464 50mg

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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion criteria:

  • 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 CTFG Guidance).

  • For HIV positive Subjects
  • 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;


Exclusion Criteria:
  • 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], HTLV-1, HTLV-2).
  • 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;
  • Severe hepatic impairment;
  • Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV
infection;

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02990325

Locations

Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Catalogna, Spain, 08916

Sponsors and Collaborators

Abivax S.A.

Investigators

Study Director: Paul GINESTE, PhD Abivax S.A.
More Information

More Information


Responsible Party: Abivax S.A.  
ClinicalTrials.gov Identifier: NCT02990325   History of Changes  
Other Study ID Numbers: ABX464-005  
Study First Received: December 7, 2016  
Last Updated: January 22, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Abivax S.A.:

ABX464, HIV infection

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.