Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients

Phase 2 Completed 151 enrolled Shanghai Pharmaceuticals Holding Co., Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic HIV infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (HAART). A total of 150 eligible subjects will be selected and randomized at a ratio of 1:1:1 into T8 0.5 mg QD, 1 mg QD, and placebo group, with background HAART unchanged, for 48 consecutive weeks.

Timeline

Start: 2019-12-25
Primary completion: 2022-07-05
Completion: 2022-07-05

Outcome

Met primary endpoint

paper LLDT-8 1 mg daily significantly increased CD4 count compared to placebo (p = 0.036) PMID 37283977 ↗

paper markedly decreased compared to -22.8 mg/L (95% CI -47.1, 1.5, p = 0.007) in placebo group. PMID 37283977 ↗

Publications

Cao W, Liu X, Han Y, Song X, Lu L, Li X, Lin L, Sun L, Liu A, Zhao H, Han N, Wei H, Cheng J, Zhu B, Wang M, Li Y, Ma P, Gao L, Wang X, Yu J, Zhu T, Routy JP, Zuo M, Li T. (5R)-5-hydroxytriptolide for HIV immunological non-responders receiving ART: a randomized, double-blinded, placebo-controlled phase II study. Lancet Reg Health West Pac. 2023 Mar 15;34:100724. doi: 10.1016/j.lanwpc.2023.100724. eCollection 2023 May.

Drugs