Antiretroviral Therapy combined with Shenling Guben Granules for the treatment of HIV infection with immune reconstitution deficiency: a randomized, double-blind, placebo-controlled study

Background: Even with long-term complete suppression of the virus through antiretroviral therapy (ART), people infected with HIV cannot attain optimal immune reconstitution. This phenomenon is called immune reconstitution deficiency, there are no effective therapeutic interventions for immune reconstitution deficiency in modern medicine. Objective: To evaluate the efficacy and safety of ART with Shenling Guben Granules Traditional Chinese medicine in boosting immunological reconstitution compared with ART alone. Methods: This was a randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the efficacy and safety of ART combined with Chinese medicine. The individuals aged 18–65 years with poor immune reconstitution following ART were included in this trial. The primary outcome was a change in the absolute value of CD4 + T lymphocytes after 72 weeks of combined ART and Chinese medicine administration. Secondary outcomes included changes in CD4 + T lymphocyte functional subpopulations, activated T lymphocyte subpopulations, CD4 + T lymphocyte proliferation, and T lymphocyte apoptosis from baseline to after 72 weeks. We also evaluated efficacy at 24- and 48-week intervals to better understand the dynamics of the trial drug’s efficacy. Results: There was a significant increase in CD4 + cell counts in groups treated with the Shenling Guben Granules after 24, 48, and 72 weeks of treatment ( P <0.05), and the difference in CD4 + cell counts at 24 weeks of treatment was statistically significant ( P =0.010). After 48 and 72 weeks of therapy, the CD4 + CD38 + cell counts in the Shenling Guben Granules group were significantly higher than in the control group ( P <0.05). In the subgroup analysis of CD4 + cell counts ≥200 cells/mm 3 , the CD4 + cell counts in the treatment group were higher than the control group after treatment for 24, 48, and 72 weeks ( P <0.05). Discussion: CD4 cell counts in HIV/AIDS patients with immunological reconstitution insufficiency can be improved to a certain extent using Shenling Guben Granules. The greater the CD4 cell count at the start, the better the therapy response. Furthermore, Shenling Guben Granules have the efficacy and safety to prevent aberrant immunological activation. A large sample size, long-term follow-up, and multiple efficacy indicators were employed to assess the therapy’s safety. Our findings will lead to new therapeutic alternatives for HIV/AIDS patients suffering from immune reconstitution deficiency. Clinical Trial Registry: Name of the registry: Sundy on promote the reconstruction of Inadequate responders in HIV/AIDS patients after combined antiretroviral therapy by Shen Ling Gu Ben Granules;Chictr.org.cn Identifier: ChiCTR1800015290, registered on March 21, 2018 (http://www.chictr.org.cn/registry.aspx).