MedTrace Logo

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

NCT07711223 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2026-07-17

No results posted yet for this study

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).

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

ACC017+FTC/TAF

ACC017+Emtricitabine/Tenofovir Alafenamide

DRUG

DTG+FTC/TAF

Dolutegravir+Emtricitabine/Tenofovir Alafenamide

Sponsors & Collaborators

  • Jiangsu Aidea Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhang F Jie, M.D., Ph.D. · Beijing Ditan Hospital

  • Cai W Ping, M.D., Ph.D. · Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2028-08-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711223 on ClinicalTrials.gov