Actively Recruiting
Phase Ib/IIa Clinical Study of ACC017 Tablets
Led by Jiangsu Aidea Pharmaceutical Group Co., Ltd. · Updated on 2024-12-05
36
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Lead Sponsor
C
Chengdu Aidea Pharmaceutical Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib/IIa Clinical Study of ACC017 Tablets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to follow study procedures
- Aged between 18 and 65 years at consent, any gender
- Body weight 40 kg or more and BMI between 18.5 and 29.9 at screening
- Documented HIV-1 infection before screening with no prior anti-HIV-1 treatment
- Agree not to use antiviral drugs other than those allowed during the study
- Plasma HIV RNA 5000 copies/mL or higher at screening
- CD4+ T-lymphocyte count above 200 cells/µL
You will not qualify if you...
- Acute HIV infection or unstable AIDS-related disease within 4 weeks before screening
- Received PrEP or PEP treatment within 1 month before screening
- Uncontrolled severe disease such as high blood pressure, NYHA class III/IV heart failure, or high fasting glucose
- History of serious allergy to drugs or foods causing life-threatening reactions or requiring drug control
- Major gastrointestinal surgery affecting drug processing within 6 months before screening or planned surgery during study
- History of cancer within 5 years except certain skin or cervical cancers treated with surgery
- Low blood counts (Hb <90 g/L, WBC <1.5x10⁹/L, ANC <0.6x10⁹/L, platelets <50x10⁹/L) at screening
- Elevated liver enzymes or bilirubin outside specified limits at screening
- Poor kidney function (SCr >1.3x ULN or creatinine clearance <60 mL/min) at screening
- Elevated blood amylase or lipase above 1.5 times normal
- Positive for hepatitis B surface antigen, hepatitis C antibody, or syphilis requiring treatment
- Smoked more than 5 cigarettes daily in last 3 months or unwilling to stop tobacco during hospitalization
- Drinks more than 14 alcohol units weekly in last 3 months or positive alcohol breath test or unwilling to stop alcohol during hospitalization
- Excessive caffeine intake (more than 8 cups daily) or unwilling to stop caffeine during hospitalization
- Consumed certain fruits or products affecting drug metabolism within 48 hours prior to first dose or unwilling to stop during hospitalization
- Use of CYP3A or UGT1A inhibitors/inducers or other drugs/herbs within 14 days or 5 half-lives before first dose
- History of drug dependence within 5 years or positive drug screen at screening
- Intolerance to blood draws or history of adverse reactions to acupuncture or blood donation, or recent blood loss/transfusion
- Special dietary requirements or refusal to accept standard diet
- Participation in another clinical trial within 3 months before screening
- Pregnant, breastfeeding, or positive pregnancy test at screening
- Planning conception or egg/sperm donation from 1 month before consent until 3 months after last dose or refusal to use contraception
- Other conditions judged by investigator as unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Ditan Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Q
Qin Hong, M.D., Ph.D.
CONTACT
L
Li Yarong, MMSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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