Clinical Trial

Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)

Recruiting Phase 1/2
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Summary
This study employs a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group, non-inferiority design. The trial will be conducted in treatment-naïve adult patients with HIV-1, using Dolutegravir Sodium Tablets as the control, to demonstrate the efficacy and safety of the core investigational drug ACC017 combined with FTC/TAF Tablets (II) compared to Dolutegravir Sodium combined with FTC/TAF Tablets (II) in treating treatment-naïve adult HIV-1 patients. After initial screening eligibility is confirmed, participants will return to the clinic on Day 1 (D1) for re-evaluation of eligibility and completion of required examinations. Eligible participants will be randomized in a 1:1 ratio to receive either ACC017 Tablets (40 mg, once daily \[QD\]) or Dolutegravir Sodium Tablets (50 mg, QD). Both treatment groups will also receive FTC/TAF Tablets (II) and will undergo 48 weeks of continuous double-blind treatment. Subsequently, all study participants will transition to open-label treatment with ACC017 combined with FTC/TAF Tablets (III) for an additional 48 weeks (during which the dummy medication will no longer be administered).
Trial Details
NCT Number NCT07711223
Lead Sponsor Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Conditions Infection, Human Immunodeficiency Virus
Enrollment 660 participants
Start Date 2025-11-07
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-17