Phase Ib/IIa Clinical Study of ACC017 Tablets
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJiangsu Aidea Pharmaceutical Group Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 asthma, urticaria, atopic dermatitis [eczema].).
Trial design
Design model
Parallel
Treatments tested in this trial
ACC017+FTC/TAF
DrugACC017+FTC/TAF
Placebo
DrugPlacebo
Treatment groups
36 Participants
are divided into 4 treatment groupsGroup A: Participant group 1Experimental treatment 1 intervention
Group B: Participant group 2Experimental treatment 1 intervention
Group C: Participant group 3Experimental treatment 1 intervention
Group D: Participant group 4Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE
Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE
Time frame
Day 1- Day 112
HIV-1 RNA viral load change from baseline
HIV-1 RNA viral load change from baseline
Time frame
Day 113
Proportion of patients with HIV-1 RNA viral load <50 copies/mL
Proportion of patients with HIV-1 RNA viral load \<50 copies/mL
Time frame
Day 294
Pharmacokinetics parameter: Cτ,ss
Cτ,ss is defined as the steady-state plasma drug concentration at the end of the dosing interval after the last administration of a given dose on the monotherapy and combination therapy periods.
Time frame
Day 10, Day 29Secondary outcomes
1
Changes over time in temperature of vital signs
Temperature in degree Celsius.
Time frame
Day 1-Day 292
Changes over time in pulse of vital signs
Pulse in beat per minute.
Time frame
Day 1-Day 293
Changes over time in systolic and diastolic blood pressure of vital signs
Systolic and diastolic blood pressure in millimeters (mm) of mercury (Hg).
Time frame
Day 1-Day 294
Changes over time in respiratory rate of vital signs
Respiratory rate in breaths per minute.
Time frame
Day 1-Day 29Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Lead sponsor
Chengdu Aidea Pharmaceutical Technology Co., Ltd
Collaborator
Source ClinicalTrials.gov