Safety and Effectiveness of JL18008 Injections Added to Standard HIV Therapy in Adults with HIV Who Have Low Immune Response A Randomized, Double-Blind, Placebo-Controlled Phase III Study

What this Trial Is About

Researchers are conducting a Phase Ib clinical trial to study the safety and effects of multiple intramuscular injections of JL18008 added to combination antiretroviral therapy cART in adults with HIV who do not show sufficient immune response despite stable treatment. The trial is multicenter, randomized, double-blind, placebo-controlled, and involves HIV immunological non-responders INRs. This study builds on earlier Phase Ia data and aims to evaluate three different JL18008 dose levels compared to placebo. Participants are divided into three dose groups receiving JL18008 at 20, 40, or 70 micrograms per kilogram once weekly for four consecutive weeks while continuing their stable cART regimen. Each dose group includes 10 subjects, with 8 receiving active drug and 2 receiving placebo injections. The treatment cycle is followed by an observation and follow-up period. All injections are given by intramuscular administration. During the study, participants will undergo regular monitoring including safety assessments of adverse events, vital signs, blood tests, ECG measurements, and immune cell counts over a 24-week period. Researchers will also measure pharmacokinetics and pharmacodynamics of JL18008, changes in CD4 T cell counts, viral load, cytokine levels, and anti-drug antibody development. The trial involves scheduled visits for drug administration and follow-up to evaluate treatment effects and safety over time.

A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders