Integrated Scheme of Traditional Chinese Medicine for Delaying the Morbidity of HIV Infection: Study Protocol for a Multicentre, Randomised Controlled Trial

Background: Acquired Immune Deficiency Syndrome (AIDS) is caused by human immunodeficiency virus (HIV) infection, the incidence and mortality rates of which are high worldwide. In the late 1990s, highly active antiretroviral therapy (ART) emerged; although it has been a long time of research on AIDS, there is still no vaccine cure. Traditional Chinese Medicine (TCM) role in AIDS has been recognised and accepted by more patients, especially patients with asymptomatic HIV infection. Methods/Design: This trial will be conducted to enrol 216 eligible patients who will be randomised into the treatment and control groups. After 18 months of intervention, the efficacy and safety of TCM in patients with AIDS will be acquired. The results include clinical symptoms, TCM syndromes, viral load, immunological indicators, safety indicators, and other biological indicators.Discussion: This study aimed to compare the effectiveness and safety of TCM for asymptomatic AIDS and explore the plausible mechanism and provide reference for adopting this approach to retard the onset and control the progression of HIV/AIDS.Trial registration: ChiCTR1800018365, 13 Sep, 2018.