The goal of this clinical trial is to learn about the function of immunomodulators in reducing HIV reservoir. The main questions it aims to answer are: * Are immunomodulators able to reduce HIV reservoirs? * How do immunomodulators reduce HIV reservoirs? Participants will be randomly and equally divided into three groups, one control group and two trial groups. All three groups will continue to receive antiretroviral therapy. The two experimental groups will additionally be given different immunomodulators lenalidomide and adenosylmethionine, respectively. The effectiveness of immunomodulatory agents in reducing viral reservoirs will be explored by comparing relevant indicators in the three groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Lenalidomide capsules (25 mg) were administered orally on days 1-21 of a 28-day cycle for 24 weeks with continuous antiretroviral therapy.
Adenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy.
the first affiliated hospital of Zhejiang university school of medicine
Hangzhou, Zhejiang, China
RECRUITINGHIV reservoirs
The size of the HIV reservoir in blood determined by HIV-DNA and CA-HIV-RNA.
Time frame: 48 weeks
Decreased inflammatory factors in HIV-infected patients
The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6.
Time frame: 48 weeks
T-cell subsets
Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.
Time frame: 48 weeks
Immune activation
Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.
Time frame: 48 weeks
Gut microbiome
Diversity and composition of gut microbiome.
Time frame: 48 weeks
Tolerability and safety outcomes
Discontinuation and occurrence of adverse event.
Time frame: 48 weeks
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