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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990325
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.

Tracking Information
First Submitted Date  ICMJE December 7, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE March 17, 2017
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • Viral Load Assessments (HIV-1 RNA copies/ml) [ Time Frame: Up to 56 days after first study treatment administration ]
  • CD4+ and CD8+ counts determinations [ Time Frame: Up to 56 days after first study treatment administration ]
  • Total HIV-1 DNA reservoir in PBMC and rectal tissue [ Time Frame: Up to 56 days after first study treatment administration ]
  • Microbiota characterization using deep sequencing [ Time Frame: Up to 56 days after first study treatment administration ]
  • 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 ]
  • Number of participants with treatment-related adverse events [ Time Frame: Up to 56 days after first study treatment administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults
Official Title  ICMJE An Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX464 in HIV-1 Seronegative and Seropositive Adults
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Health Volunteers
Intervention  ICMJE
  • Drug: ABX464 150mg
    ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
  • 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)
Study Arms  ICMJE
  • Experimental: ABX464 150mg
    ABX464, 50mg per Capsule Three Capsules per day for 28 days
    Intervention: Drug: ABX464 150mg
  • Experimental: ABX464 50mg
    ABX464, 50mg per Capsule One Capsule per day for 28 or 84 days
    Intervention: Drug: ABX464 50mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990325
Other Study ID Numbers  ICMJE ABX464-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abivax S.A.
Study Sponsor  ICMJE Abivax S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul GINESTE, PhD Abivax S.A.
PRS Account Abivax S.A.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP