Actively Recruiting
Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals
Led by Shanxi Kangbao Biological Product Co., Ltd. · Updated on 2026-05-11
30
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Shanxi Kangbao Biological Product Co., Ltd.
Lead Sponsor
I
Institute of Pathogen Biology, Beijing, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 for Injection in Antiretroviral Therapy-Naive HIV-Infected Individuals
CONDITIONS
Official Title
Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent to participate in the study
- Age between 18 and 65 years inclusive at screening
- Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg
- Plasma HIV RNA level of at least 1000 copies/mL and CD4+ T lymphocyte count of at least 200 cells/μL
- Female participants must be non-reproductive due to surgical sterilization or postmenopausal for at least 12 months with confirmed FSH level
- Male subjects with fertile female partners must agree to use non-pharmacological contraception during the study and for 3 months after
- Willingness to comply with study visits, treatment, and procedures
You will not qualify if you...
- Known allergy or severe allergic reactions to the study drug or its components
- Previous antiviral therapy or HIV vaccination
- History of severe disease or other serious chronic conditions
- History of mental health disorders or family history of psychiatric diseases
- Persistent unexplained fever or diarrhea within 1 month before screening
- Severe or opportunistic infections or sepsis within 6 months prior to screening
- Positive for hepatitis B surface antigen or hepatitis C antibody
- Clinically significant abnormal ECG findings at screening
- Elevated liver enzymes or bilirubin above 1.5 times upper limit of normal
- Serum creatinine clearance below 60 mL/min at screening
- History or suspicion of drug abuse or positive drug screening
- History of alcohol abuse within the past year or inability to comply with alcohol restrictions
- Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to comply with smoking restrictions
- Receipt of any vaccine within 3 months prior to screening or planned vaccination during the study
- Participation in other investigational drug or device trials within 3 months prior to dosing
- Major surgery within 30 days prior to dosing or planned during the study
- Blood donation or loss of 400 mL or more within 3 months prior to screening or blood transfusion during this period
- Any other condition making the participant unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
Y
Yuxian He, Doctor
CONTACT
F
Fan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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