RecruitingPhase 1Phase 2NCT06719310

Phase Ib/IIa Clinical Study of ACC017 Tablets

A Phase Ib/IIa, Randomized, Double Blinded, Perallel, Dosing Ranging, Placebo Controled and Proof of Concept Clinical Trial to Evaluate the Safety, Tolerability, PK and Antiviral Effect of ACC017 Tablet as Monotherapy/Combination With NRTI in Treatment naïve HIV-infected Adults


Sponsor

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

Enrollment

36 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new HIV treatment called ACC017 in adults living with HIV-1 who have never been treated with antiretroviral medications before. The goal is to see how safe the drug is and how well it reduces the amount of virus in the blood. **You may be eligible if...** - You are between 18 and 65 years old - You have confirmed HIV-1 infection and have never taken any anti-HIV medications or vaccines - Your viral load is high (HIV RNA at least 5,000 copies per mL) - Your immune cell count (CD4+ T cells) is above 200 cells per microliter - Your weight is at least 40 kg and your BMI is in the normal-to-overweight range (18.5–29.9) **You may NOT be eligible if...** - You have recently been diagnosed with acute HIV infection or have an unstable AIDS-related illness - You used HIV prevention medications (PrEP or PEP) in the past month - You have uncontrolled high blood pressure, serious heart disease, or uncontrolled diabetes - You have a history of severe drug or food allergies - You have had major abdominal surgery affecting drug absorption Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGACC017+FTC/TAF

ACC017+FTC/TAF

DRUGPlacebo

Placebo


Locations(1)

Beijing Ditan Hospital, Capital Medical University

Beijing, China

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NCT06719310