Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals (NCT07433387) | Clinical Trial Compass
RecruitingPhase 1/2
Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals
China30 participantsStarted 2026-01-29
Plain-language summary
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
Who can participate
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.
Inclusion criteria
. The subject must voluntarily agree to participate in the study and provide informed consent before undergoing any study-related assessments.
. At the time of screening, the subject must be between 18 and 65 years of age (inclusive), either male or female.
. At the time of screening, male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg.
. Plasma HIV RNA levels must be ≥1000 copies/mL, and CD4+ T lymphocyte count must be ≥200 cells/μL.
. For Female Subjects: Only non-reproductive females will be included, which includes those who have undergone surgical sterilization (documented hysterectomy or bilateral oophorectomy) at least 6 weeks prior to the screening visit, or those who have been postmenopausal for at least 12 months (confirmed by a follicle-stimulating hormone (FSH) level ≥40 IU/L).
. For Male Subjects with Fertile Female Partners: The subject must agree to use a non-pharmacological contraception method for 14 days prior to dosing, during the study, and for 3 months following the administration of the study drug. Male subjects must not donate sperm during this period.
. The subject must be willing to adhere to the study protocol, including visits, study treatment, laboratory tests, and other study-related procedures and requirements.
Exclusion criteria
Questions worth asking your doctor
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma HIV RNA levels (log10 copies/mL) and changes from baseline
Timeframe: Within 71 days after the first administration.
2
Proportion of subjects with plasma HIV RNA < 50 copies/mL
Timeframe: Within 71 days after the first administration.
3
Proportion of subjects with plasma HIV RNA < 200 copies/mL
Timeframe: Within 71 days after the first administration.
4
Absolute CD4+ T lymphocyte count and change from baseline
Timeframe: Within 71 days after the first administration.
5
CD4+/CD8+ T lymphocyte ratio and change from baseline
Timeframe: Within 71 days after the first administration.