Abstract
BACKGROUND: Amphetamine-type stimulant (ATS) abuse is strongly associated with an elevated risk of HIV infection and transmission. Antiretroviral therapy (ART) serves as the primary approach for managing HIV infection and AIDS progression. However, ATS abuse diminishes the efficacy of ART in HIV/AIDS patients, amplifying the vulnerability to immunological non-response (INR) and ultimately increasing the incidence rate and mortality of opportunistic infections. Currently, no effective interventions targeting INR exist. Acupuncture has demonstrated promise in bidirectionally modulating the body's immune response and may be beneficial for INR in HIV/AIDS combined with ATS abuse. Nevertheless, further research and comprehensive evaluation are imperative to substantiate these findings. METHODS: This study is a two-center, randomized, non-acupoint controlled, single-blind clinical trial. It will be conducted in two large drug rehabilitation centers in western China, involving 114 INR patients receiving ART. The participants will be randomly assigned to either the Transcutaneous Electrical Acupoint Stimulation (TEAS) + ART group or the sham-TEAS + ART group, in a 1:1 ratio. Both groups will receive a 48-week treatment. The primary outcome measure assessed after treatment is the CD4 + T cell count. Secondary outcome measures include the immune reconstitution efficiency of HIV patients, CD4/CD8 ratio, CD4 + CD45RA + and CD4 + CD45RO + counts, CD4 + CD28 + counts, CD4 + CD38 + and CD8 + CD38 + counts, CD4 + ki67 + and CD8 + ki67 + counts, JC mitochondrial membrane potential testing, the incidence of opportunistic infections, and the HIV/AIDS PRO scale. Adverse events occurring during the study observation period will be documented. DISCUSSION: This study will investigate the effect of TEAS on immune reconstitution in patients with amphetamine abuse and HIV infection. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR 2300076363. Registered on October 7, 2023, https://www.chictr.org.cn/ .