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

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abivax S.A.
• Collaborator: FLS-RS

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;