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Can a new pill tame HIV? early trial puts ACC017 to the test

NCT ID NCT06719310

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This early-stage trial is testing an experimental HIV drug called ACC017 in adults with HIV-1 who have never taken HIV medication. The study aims to see if the drug is safe, tolerable, and effective at lowering the amount of virus in the blood, both when used alone and when combined with another HIV treatment (FTC/TAF). Participants will be randomly assigned to receive one of three doses of ACC017 or a placebo, and the trial will monitor side effects and viral load changes over about a month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ACC017, an experimental integrase inhibitor drug, tested alone and in combination with FTC/TAF
What this could lead to
If successful, this could lead to a new treatment option for HIV that helps control the virus with fewer side effects or resistance issues.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not hold up in larger studies. The drug may also cause side effects or fail to suppress the virus effectively.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

36 people

The number who actually took part.

Started

Aug 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 11. 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. 12. Average smoked cigarettes more than 5 a day within 3 months prior to screening or unwilling to stop using any tobacco products during hospitalization. 13. 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. 14. 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. 15. 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. 16. 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). 17. 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). 18. 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). 19. 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. 20. 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. 21. Have special dietary requirements at screening, or refuse to accept a standard diet. 22. Have participated in or are participating in another drug or medical device clinical study within 3 months prior to screening. 23. Women who are pregnant or breastfeeding or who have a positive blood pregnancy test at screening. 24. 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. 25. Other conditions exist that, in the judgement of the investigator, make participation in this study unsuitable.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.