BridgeMD
New treatment option for Infection, Human Immunodeficiency Virus
Official title Phase Ib/IIa Clinical Study of ACC017 Tablets
ClinicalTrials.gov ID: NCT06719310
What this study is testing
What is ACC017+FTC/TAF?
ACC017+FTC/TAF is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for infection, human immunodeficiency virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
- History of serious allergy to drugs (such as aspirin or cephalosporin antibiotics) or their ingredients' or food (a fast, life-threatening systemic...
- Any major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy) or any surgery affecting drug absorption, distribution...
- History of cancer(except cervical carcinoma in situ, or cutaneous basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ [Bowen's...
See the full eligibility criteria
Who can 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
What rules you out
- 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...
- 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...
- 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...
- 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
- people 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Other conditions exist that, in the judgement of the investigator, make participation in this study unsuitable.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.