Conditions: HIV Infections Health Volunteers
Keywords: ABX464, HIV infection
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: yes

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.

Arms:
arm 1: ABX464, 50mg per Capsule Three Capsules per day for 28 days arm 2: ABX464, 50mg per Capsule One Capsule per day for 28 days arm 3: ABX464, 50mg per Capsule One Capsule per day for 84 days

Interventions: intervention 1: ABX464 150mg intervention 2: ABX464 50mg intervention 3: ABX464 50mg
Intervention descriptions: intervention 1: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects) intervention 2: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects) intervention 3: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)

Protocol document:
Prot_000.pdf: 

































































































SAP_001.pdf: