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 range18 Years – 65 Years
SexALL
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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
✕. Known allergy to the study drug or its excipients, or a history of severe allergic reactions (including any food allergies or drug allergies).
✕. Has previously received antiviral therapy (ART) or has been vaccinated against HIV.
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.