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.
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE
Timeframe: Day 1- Day 11
HIV-1 RNA viral load change from baseline
Timeframe: Day 11
Proportion of patients with HIV-1 RNA viral load <50 copies/mL
Timeframe: Day 29
Pharmacokinetics parameter: Cτ,ss
Timeframe: Day 10, Day 29
Pharmacokinetics parameter: Cmin,ss
Timeframe: Day 10
Pharmacokinetics parameter: Cmax,ss
Timeframe: Day 10
Pharmacokinetics parameter: AUC0-τ,ss
Timeframe: Day 1- Day 10
Pharmacokinetics parameter: Tmax,ss
Timeframe: Day 1-Day 10
Pharmacokinetics parameter: MRT0-τ,ss
Timeframe: Day 1-Day 10