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

This study is currently recruiting participants.
Verified June 2017 by Abivax S.A.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02990325
First Posted: December 13, 2016
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
FLS-RS
Information provided by (Responsible Party):
Abivax S.A.
  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 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group 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

Resource links provided by NLM:


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 56 days after first study treatment administration ]
    Pharmacokinetic parameters


Secondary Outcome Measures:
  • HIV-1 RNA copies/ml [ Time Frame: Up to 56 days after first study treatment administration ]
    Viral Load Assessments

  • CD4+ and CD8+ counts (Cell/mm3) [ Time Frame: Up to 56 days after first study treatment administration ]
    T-cell determinations

  • Total HIV-1 DNA reservoir in PBMC and rectal tissue [ Time Frame: Up to 56 days after first study treatment administration ]
    HIV reservoir cells

  • Microbiota characterization using deep sequencing [ Time Frame: Up to 56 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 56 days after first study treatment administration ]
    T-cell function determinations

  • Number of participants with treatment-related adverse events [ Time Frame: Up to 56 days after first study treatment administration ]
    Safety


Estimated Enrollment: 36
Actual Study Start Date: March 17, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABX464
ABX464, 50mg per Capsule Three Capsules par day for 28 days
Drug: ABX464
ABX464 given orally at 150 mg per day from Day 0 to Day 28

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-infected and 12 HIV-uninfected) and will receive 150 mg ABX464 orally once daily for 28 days. (Cohort 2)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990325


Contacts
Contact: Paul GINESTE +33 1 53 83 09 61 paul.gineste@abivax.com
Contact: Jean-Marc STEENS, MD +33 1 53 83 09 61 Jean-marc.steens@abivax.com

Locations
Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Catalogna, Spain, 08916
Contact: Roser Escrig Sarreta    +34 93 497 84 14    rescrig@fls-rs.com   
Principal Investigator: Ross Cranston, MD         
Sponsors and Collaborators
Abivax S.A.
FLS-RS
Investigators
Study Director: Paul GINESTE, PhD Abivax S.A.
  More Information

Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT02990325     History of Changes
Other Study ID Numbers: ABX464-005
First Submitted: December 7, 2016
First Posted: December 13, 2016
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases


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