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RECRUITINGPHASE1/PHASE2

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

NCT06719310•Jiangsu Aidea Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

This phase Ib/IIa study in HIV-infected antiretroviral naive adult subjects is conducted to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of ACC017 tablet as monotherapy/combination with NRTIs and to explore the recommended dose for the future pivotal clinical trial of ACC017. The study will be conducted as two stages. Stage one will includes a dose-ranging evaluation of ACC017 5mg, 40mg and 80mg once daily compared to placebo on the basis of safety, tolerability, pharmacokinetics and antiviral activity. Subjects will be randomized in a 5:1 ratio to receive one of three doses of ACC017 or placebo. Each subject will receive ACC017 tablet as monotherapy for 10 days and then followed by a combination with NRTIs for 18 days. In monotherapy, the enrolment into the next higher dose group will commence only when investigator and sponsor both agree that ACC017 is safe and well tolerated at a given dose. Stage two is open and subjects will continue to take ACC017 at the dose given on stage one in combination with FTC/TAF tablet at 200 mg/25 mg once daily for 18 days. Subjects randomized to receive placebo in stage one will receive the equivalent dose of ACC017 combined with FTC/TAF.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing to sign the informed consent and agree to comply to the study procedures and requests
•2. Age range between 18 and 65 years old at the time of signing informed consent, regardless of gender
•3. Body weight ≥40 kg, and BMI range between 18.5\~29.9 kg/m2 (including the borderline) at screening
•4. Documented HIIV-1 infection before screening, and never receive any antiHIV-1 drugs or vaccines after the diagnosis of HIV-1 infection
•5. Agree not to use any antiviral drugs other than those allowed by protocol during study period.
•6. Plasma HIV RNA≥5000 copies/mL at screening;
•7. CD4+ T-lymphocyte count of \>200 cells/μL

Exclusion Criteria

•1. Diagnosis of acute HIV infection at screening or unstable AIDS related disease within 4 weeks prior to screening.
•2. Had PrEP and/or PEP treatment within 1 month prior to screening.
•3. Had uncontrolled severe disease judged by investigator, such as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, NYHA class III or IV or fasting glucose ≥7.0 mmol/L.
•4. History of serious allergy to drugs (such as aspirin or cephalosporin antibiotics) or their ingredients' or food (a fast, life-threatening systemic allergic reaction), or allergic disease requiring drug control (such as asthma, urticaria, atopic dermatitis \[eczema\].).
•5. Any major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy) or any surgery affecting drug absorption, distribution, metabolism and excretion within 6 months before screening; or possible elective surgery during the trial as judged by the investigator.
•6. History of cancer(except cervical carcinoma in situ, or cutaneous basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ \[Bowen's disease\] that received radical surgery or treatment) within 5 years prior to screening.
•7. Hb \<90 g/L, or WBC count \<1.5×109/L, or ANC count \<0.6×109/L, or platelet count \<50×109/L at screening.
•8. ALT and/or AST \> 2.5 times upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or DBIL \> ULN, or ALB \<30 g/L at screening.
•9. SCr \> 1.3 ×ULN, or Ccr \<60 mL/min (Cockcroft-Gault formula) at screening,
•10. Blood amylase or lipase \>1.5 ×ULN
+15 more criteria

Locations (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

August 28, 2024

Primary Completion Date

August 1, 2025

Completion Date

November 1, 2025

Last Updated

December 5, 2024

Enrollment

ESTIMATED participants

Conditions

Infection, Human Immunodeficiency Virus

Interventions

ACC017+FTC/TAF

DRUG

Placebo

DRUG

Contacts

Qin Hong, M.D., Ph.D.

CONTACT

025-83193135 qinh@aidea.com.cn

Li Yarong, MMSC

CONTACT

liyarong@aidea.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Phase Ib/IIa Clinical Study of ACC017 Tablets

Inclusion Criteria

Exclusion Criteria

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