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Compares treatment options for Infection, Human Immunodeficiency Virus
Official title Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)
ClinicalTrials.gov ID: NCT07711223
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
- This study employs a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group, non-inferiority design. The trial will be conducted in treatment-naïve adult patients with HIV-1, using Dolutegravir Sodium Tablets as the control, to demonstrate the efficacy and safety of the core investigational drug ACC017 combined with FTC/TAF Tablets (II) compared to Dolutegravir Sodium combined with FTC/TAF Tablets (II) in treating treatment-naïve adult HIV-1 patients.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A participant will be excluded from the trial if they meet any one or more of the following criteria:
- Voluntarily sign the written informed consent form, demonstrate the ability to understand and comply with the requirements of the study protocol;
- Age ≥18 years (inclusive) at the time of providing informed consent, both male and female participants are eligible;
- Diagnosed with HIV infection prior to informed consent, and have an HIV RNA viral load ≥500 copies/mL (tested at the local center) at screening;
- Have not received any ART since initial HIV diagnosis, and agree not to initiate any ART from the time of informed consent until randomization.
You likely can't join if
- Participants judged by the investigator as having poor treatment compliance or protocol adherence, or any other condition making them unsuitable for...
- At screening, female participants who are pregnant, breastfeeding, or have a positive blood pregnancy test; or from 1 month before screening until 3...
- At screening, judged by the investigator to be in the acute phase of HIV-1 infection, or with opportunistic infections or other clinically...
- At screening, judged by the investigator to have poorly controlled clinically significant diseases (including cardiovascular, respiratory, digestive...
- At screening, judged by the investigator to have clinically significant laboratory abnormalities, including but not limited to: hemoglobin (Hb) \ 5 ×...
- At screening, HBsAg-positive with HBV DNA ≥2000 IU/mL (local center testing), HCV antibody-positive with HCV RNA \> LLOQ (local center testing), or...
See the full eligibility criteria
- A participant will be excluded from the trial if they meet any one or more of the following criteria:
- Voluntarily sign the written informed consent form, demonstrate the ability to understand and comply with the requirements of the study protocol;
- Age ≥18 years (inclusive) at the time of providing informed consent, both male and female participants are eligible;
- Diagnosed with HIV infection prior to informed consent, and have an HIV RNA viral load ≥500 copies/mL (tested at the local center) at screening;
- Have not received any ART since initial HIV diagnosis, and agree not to initiate any ART from the time of informed consent until randomization.
- Participants judged by the investigator as having poor treatment compliance or protocol adherence, or any other condition making them unsuitable for the study, or when participation may not best protect the...
- At screening, female participants who are pregnant, breastfeeding, or have a positive blood pregnancy test; or from 1 month before screening until 3 months after the last dose of the investigational product...
- At screening, judged by the investigator to be in the acute phase of HIV-1 infection, or with opportunistic infections or other clinically significant AIDS-defining conditions within 3 months before screening;
- At screening, judged by the investigator to have poorly controlled clinically significant diseases (including cardiovascular, respiratory, digestive, endocrine-metabolic, neuropsychiatric, hematological, and immune...
- At screening, judged by the investigator to have clinically significant laboratory abnormalities, including but not limited to: hemoglobin (Hb) \ 5 × ULN, or ALT \>3 × ULN with total bilirubin (TBIL) \>1.5 × ULN, or...
- At screening, HBsAg-positive with HBV DNA ≥2000 IU/mL (local center testing), HCV antibody-positive with HCV RNA \> LLOQ (local center testing), or judged by the investigator to require anti-syphilis treatment...
- Use of pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP) within 1 month before screening, or prior use of long-acting PrEP drugs (e.g., cabotegravir or lenacapavir, etc.);
- Within 30 days before screening, at screening, or planned use during the trial, systemic immunomodulators, cytotoxic drugs, etc. (see Appendix 7), and unwilling or unable to discontinue use from the time of informed...
- At screening, known history of allergy to the investigational product, structurally related drugs, or excipients; or history of allergic diseases requiring medication control before screening (e.g., asthma, urticaria...
- Before screening, major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy); or at screening, judged by the investigator as likely to require elective major surgery during the trial;
- Within 5 years before screening, history of malignancy (except carcinoma in situ of the cervix treated by conization, or surgically cured basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ [Bowen's...
- Within 5 years before screening, history of alcohol, drug, or other substance abuse (non-medical excessive, inappropriate, or addictive use of alcohol, drugs, or other substances leading to social, psychological, or...
- Before or at screening, intolerance to venipuncture, history of needle or blood phobia, or blood donation (including component blood) or significant blood loss (≥400 mL) or transfusion within 3 months before screening...
- Participation in any treatment clinical trial (including drugs, vaccines, or devices) within 3 months before screening.
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 and older. 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.