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Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance Mutations

NCT07711210 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-17

No results posted yet for this study

Summary

This trial is a randomized, double-blind, placebo-controlled clinical study conducted in treatment-experienced adults with NNRTI-resistant HIV-1, designed to preliminarily evaluate the efficacy, safety, and resistance profile of the core drug ACC017 in this population.

The study consists of two treatment phases: a functional monotherapy period (double-blind phase) and an extended optimized treatment period (open-label phase).

The first phase is the functional monotherapy period (W1-W2). After initial screening, eligible participants will return to the hospital on D1 for final eligibility review and baseline examinations. Those who pass the review will be randomized in a 2:1 ratio to either ACC017 tablets (N=8, 40 mg, once daily \[QD\]) or matching placebo (N=4), replacing the core NNRTI drug in the failing background regimen while maintaining the original backbone NRTIs unchanged. Treatment will continue for 2 weeks.

The second phase is the extended optimized treatment period (W3-W16). All participants who complete the functional monotherapy period will receive ACC017 tablets (40 mg QD) in combination with an optimized backbone regimen (i.e., ACC017 replaces the core NNRTI drug in the failing background regimen, while the investigator adjusts the backbone drugs based on HIV genotypic resistance test results to ensure at least one backbone NRTI remains sensitive, if applicable). Treatment will continue for 14 weeks.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

ACC017

ACC017

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Jiangsu Aidea Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhang R Fang · Shanghai Clinical Center for Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2027-06-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07711210 on ClinicalTrials.gov