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Infection, Human Immunodeficiency VirusPhase 1/2NCT06719310

Phase Ib/IIa Clinical Study of ACC017 Tablets

A Phase 1/2 study testing ACC017+FTC/TAF in people with Infection, Human Immunodeficiency Virus, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Infection, Human Immunodeficiency Virus
What is being tested?
ACC017+FTC/TAF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteChina
Study dates
28 Aug 2024to 28 Apr 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Diagnosis of acute HIV infection at screening or unstable AIDS related disease within 4 weeks prior to screening.
  • Had PrEP and/or PEP treatment within 1 month prior to screening.
  • 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.
  • 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].).
  • 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.
  • 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.
Show all 25Show fewer
  • 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.
  • 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.
  • SCr > 1.3 ×ULN, or Ccr <60 mL/min (Cockcroft-Gault formula) at screening,
  • Blood amylase or lipase >1.5 ×ULN
  • Subjects with a positive for HBsAg or anti-HCV, or those with anti-Tp positive who need to be treated required by investigator or their treatment period <7 days at screening.
  • Average smoked cigarettes more than 5 a day within 3 months prior to screening or unwilling to stop using any tobacco products during hospitalization.
  • Drinking more than 14 units per week within 3 months prior to screening ( 1 unit of alcohol is equivalent to 5% beer, 45 mL of 40% alcohol, 150mL of 12% alcohol), or a positive alcohol breath test at a screening or baseline visit, or unwilling to stop drink any alcohol-containing product during hospitalization.
  • Excessive consumption of tea, coffee or caffeine ( more than 8 cups per day on average, 1 cup of 250 mL) or unwilling to stop drinking tea, coffee, or caffeine during hospitalization.
  • Having taken pitaya, mango, grapefruit, star fruit or any preparations made from them, or food/drinking containing xanthine, caffeine or alcohol (e.g.chocolate, tea, coffee, cola and cocoa) or others that will affect the absorption, distribution, metabolism, excretion of drugs, within 48 hours prior to the first dose of experimental drugs, or unwilling to stop taking them during hospitalization.
  • Use of any potent or moderate CYP3A inhibitors (e.g. clarithromycin, thalimycin, ketocomazole, ketoconazole, itraconazole, and CYP3A4) or potent CYP3A4 inducers (e.g. rifampin, efavirenz,carbamazepine, phenobarbitone, phenytoin) within 14 days prior to the first dose of experimental drugs or within 5 half-lives(whichever is longer).
  • Use of any potent or moderate UGT1A inhibitors (e.g. silybin. Ritonavir) or potent UGT1A1 inducers (e.g. rifampin, carbamazepine) within 14 days prior to the first dose of experimental drugs or within 5 half-lives (whichever is longer).
  • Use of any prescription drug, nonprescription drug, Chinese traditional herbs within 14 days prior to the first dose of experimental drugs or within 5 half-lives (whichever is longer).
  • History of drug dependence (social, psychological and physical impairment due to excessive, impropriate or addictive use of substances for any non-medical reason) within 5 years prior to screening, or positive urine drug screen at screening or baseline.
  • Intolerance to venipuncture, or have a history of halo acupuncture or blood sickness, or have donated blood including component blood or have had substantial blood loss (more than 400 mL) or have received a blood transfusion within 3 months prior to screening, or plan to donate blood during study.
  • Have special dietary requirements at screening, or refuse to accept a standard diet.
  • Have participated in or are participating in another drug or medical device clinical study within 3 months prior to screening.
  • Women who are pregnant or breastfeeding or who have a positive blood pregnancy test at screening.
  • Have a birth plan (including conception, eggs or sperm donation) within 1 month before signing informed consent form until 3 months after last dose of experimental drugs or refuse to use effective any contraceptive methods.
  • Other conditions exist that, in the judgement of the investigator, make participation in this study unsuitable.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Ditan Hospital, Capital Medical University

    Beijing

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
ACC017+FTC/TAF, Placebo
Medical subject headings
Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACC017+FTC/TAFDrug

    ACC017+FTC/TAF

  • PlaceboDrug

    Placebo

Study groups in NCT06719310
Study groupRoleWhat they receive
Participant group 1ExperimentalStage one: ACC017 (Dose 1) Stage two: ACC017 (Dose 1)+FTC/TAF (200mg/25mg) QD
Receives: Drug: ACC017+FTC/TAF
Participant group 2ExperimentalStage one: ACC017 (Dose 2) Stage two: ACC017 (Dose 2)+FTC/TAF (200mg/25mg) QD
Receives: Drug: ACC017+FTC/TAF
Participant group 3ExperimentalStage one: ACC017 (Dose 3) Stage two: ACC017 (Dose 3)+FTC/TAF (200mg/25mg) QD
Receives: Drug: ACC017+FTC/TAF
Participant group 4Placebo comparatorStage one: Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE

    Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE

    Measured: Day 1- Day 11

  2. HIV-1 RNA viral load change from baseline

    HIV-1 RNA viral load change from baseline

    Measured: Day 11

  3. Proportion of patients with HIV-1 RNA viral load <50 copies/mL

    Proportion of patients with HIV-1 RNA viral load <50 copies/mL

    Measured: Day 29

  4. Pharmacokinetics parameter: Cτ,ss

    Cτ,ss is defined as the steady-state plasma drug concentration at the end of the dosing interval after the last administration of a given dose on the monotherapy and combination therapy periods.

    Measured: Day 10, Day 29

  5. Pharmacokinetics parameter: Cmin,ss

    Cmin,ss is defined as the minimum steady-state plasma drug concentration after the last dose of monotherapy.

    Measured: Day 10

  6. Pharmacokinetics parameter: Cmax,ss

    Cmax,ss is defined as the maximum steady-state plasma drug concentration after the last dose of monotherapy.

    Measured: Day 10

  7. Pharmacokinetics parameter: AUC0-τ,ss

    AUC0-τ,ss is defined as the steady-state area under the plasma concentration-time curve from time zero to the any dosing interval of monotherapy.

    Measured: Day 1- Day 10

  8. Pharmacokinetics parameter: Tmax,ss

    Tmax,ss is defined as the time to reach steady-state maximum plasma concentration during monotherapy period.

    Measured: Day 1-Day 10

  9. Pharmacokinetics parameter: MRT0-τ,ss

    MRT0-τ,ss is defined as the steady-state mean residence time from time zero to any dosing interval of monotherapy.

    Measured: Day 1-Day 10

Secondary outcomes (21)

  1. Changes over time in temperature of vital signs

    Temperature in degree Celsius.

    Measured: Day 1-Day 29

  2. Changes over time in pulse of vital signs

    Pulse in beat per minute.

    Measured: Day 1-Day 29

  3. Changes over time in systolic and diastolic blood pressure of vital signs

    Systolic and diastolic blood pressure in millimeters (mm) of mercury (Hg).

    Measured: Day 1-Day 29

  4. Changes over time in respiratory rate of vital signs

    Respiratory rate in breaths per minute.

    Measured: Day 1-Day 29

  5. Changes over time in heart rate as measured by electrocardiogram(ECG)

    Heart rate in beat per minute.

    Measured: Day 1-Day 29

  6. Changes over time in PR interval as measured by ECG

    PR interval is measured by ECG.

    Measured: Day 1-Day 29

  7. Changes over time in QRS duration

    QRS duration is measured by ECG.

    Measured: Day 1-Day 29

  8. Changes over time in QTc interval

    QTc interval is measured by ECG.

    Measured: Day 1-Day 29

  9. Changes over time in weight

    Weight is in kilograms.

    Measured: Day 1-Day 29

  10. Pharmacokinetics parameters: Cmax

    The maximum drug concentration following the first dose of monotherapy.

    Measured: Day 1-Day 2

  11. Pharmacokinetics parameters: Cτ

    The drug concentration on the end of the first dosing interval of monotherapy.

    Measured: Day 2

  12. Pharmacokinetics parameters: AUC0-τ

    AUC0-τ is defined as the area under the plasma concentration-time curve from time zero to the first dosing interval of monotherapy.

    Measured: Day 2

  13. Pharmacokinetics parameters: Tmax

    Time to reach the maximum drug concentration after the first dose of monotherapy.

    Measured: Day 1- Day 2

  14. Pharmacokinetics parameters: MRT0-τ

    MRT0-τ is defined as the steady-state mean residence time from time zero to the first dosing interval of monotherapy.

    Measured: Day 1- Day 2

  15. Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE

    Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE

    Measured: Day 11-Day 29

  16. HIV-1 RNA viral load changes from baseline over time

    HIV-1 RNA viral load changes from baseline over time

    Measured: Day 2-Day 4, Day 8-Day 11, Day 21, Day 29

  17. Proportion of patients with HIV-1 RNA viral load <50 copies/mL

    Proportion of patients with HIV-1 RNA viral load <50 copies/mL

    Measured: Day 11

  18. Proportion of patients with HIV-1 RNA viral load <200 copies/mL

    Proportion of patients with HIV-1 RNA viral load <200 copies/mL

    Measured: Day 11, Day 29

  19. The proportion of patients with HIV-1 RNA viral load <400 copies/mL

    The proportion of patients with HIV-1 RNA viral load <400 copies/mL

    Measured: Day 11, Day 29

  20. Changes in viral load from baseline to HIV-1 RNA viral load at nadir

    Changes in viral load from baseline to HIV-1 RNA viral load at nadir

    Measured: Day 11

  21. The proportion of nadir HIV-1 RNA <50 copies/mL

    The proportion of nadir HIV-1 RNA <50 copies/mL

    Measured: Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2024
  2. Study start28 Aug 2024
  3. Primary completion28 Apr 2025
  4. Study completion28 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719310
Sponsor's protocol ID
ADYY-ACC017-103&amp;201
Status last verified
Aug 2026
First submitted
26 Nov 2024
Last updated
14 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ACC017+FTC/TAF in people with Infection, Human Immunodeficiency Virus, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE (time frame: Day 1- Day 11). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06719310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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