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

ABIVAX

Status and phase: Completed; Phase 2; Phase 1

Conditions: Health Volunteers; HIV Infections

Treatments: Drug: ABX464 50mg; Drug: ABX464 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02990325

ABX464-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 Clinical Trials Facilitation and Coordination Group (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].
• Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

ABX464 150mg

Experimental group

Description:

ABX464, 50mg per Capsule Three Capsules per day for 28 days

Treatment:

Drug: ABX464 150mg

ABX464 50mg for 28 days

Experimental group

Description:

ABX464, 50mg per Capsule One Capsule per day for 28 days

Treatment:

Drug: ABX464 50mg

Drug: ABX464 50mg

ABX464 50mg for 84 days

Experimental group

Description:

ABX464, 50mg per Capsule One Capsule per day for 84 days

Treatment:

Drug: ABX464 50mg

Drug: ABX464 50mg