Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)
Recruiting
Phase 1
Phase 2
Interventional Study
Infection, Human Immunodeficiency Virus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 660 (estimated)
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd. · Industry
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About This Trial
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 Sodi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
A participant will be excluded from the trial if they meet any one or more of the following criteria:
1. Voluntarily sign the written informed consent form, demonstrate the ability to understand and comply with the requirements of the study protocol;
2. Age ≥18 years (inclusive…
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