Phase Ib/IIa Clinical Study of ACC017 Tablets

ACC017 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase Ib/IIa, randomized, double-blind, parallel, dose ranging, placebo-controlled 'proof of concept' study is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of ACC017 monotherapy and combined with FTC/TAF by sequency versus placebo in treatment-naïve HIV-1 infected adults. This study includes two stages, stage one is a single dose escalation, and all subjects will be co-administrated with FTC/TAF at 200 mg/25 mg on stage two. The study consists of a screening visit, baseline period, monotherapy period, and combination therapy period. Total 36 subjects will be randomized in a 5:1 ratio to receive one of three doses of ACC017 or placebo lasting for 10 days for monotherapy followed by 18 days for combination therapy.

NCT Number	NCT06719310
Lead Sponsor	Jiangsu Aidea Pharmaceutical Group Co., Ltd. Collaborators: Chengdu Aidea Pharmaceutical Technology Co., Ltd
Conditions	Infection, Human Immunodeficiency Virus
Enrollment	36 participants
Start Date	2024-08-28
Primary Completion	2025-04-28 (estimated)
Study Completion	2025-04-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-14