Clinical intervention study of Chinese and Western medicine in people with AIDS immunocompromised state

Phase 1

• Conditions: AIDS

• Registration Number: ITMCTR2200005974
• Lead Sponsor: Hubei Provincial Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? HIV antibody positive, confirmed by Western Blot confirmation test;
? Voluntary acceptance of HAART;
? CD4+ cell count <350 cells/µL;
? The subjects are between 18-65 years old, male or female;
? TCM syndrome differentiation is in line with lung-spleen deficiency syndrome or liver-kidney essence deficiency syndrome;
? Voluntarily participate in this study, sign the informed consent form, and follow up on time.

Exclusion Criteria

? Those with uncontrolled serious opportunistic infections (Pneumocystis pneumonia, meningitis, esophageal Candida infection, lymphoma, Toxoplasma encephalopathy, tuberculosis, etc.) before enrollment;
? Patients who are participating in clinical trials of other drugs within 1 month before enrollment;
? Those who received immunomodulatory therapy within 1 month before enrollment;
? White blood cell (WBC) count <2.0×109/L, or neutrophil (N) count <1.0×109/L, or hemoglobin (Hb) amount <90g/L, or platelet (PLT) count <75×109 /L, or liver or renal insufficiency (aspartate aminotransferase (AST), aspartate aminotransferase (ALT), total bilirubin (TBIL) = 2 times the upper limit of the reference value or urea nitrogen (BUN) ), serum creatinine (Scr) detection value = 1.2 times the upper limit of the reference value);
? Patients with pancreatitis and active gastric ulcer;
? Patients with clinically significant active diseases of the respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, and urogenital system;
? Those who suffer from autoimmune diseases;
? Tumor patients who need chemotherapy;
? Pregnant or breastfeeding women and women of childbearing age who do not use safe contraception;
? allergic constitution;
? Patients with intellectual or language barriers who cannot fully understand the test content or give good cooperation;
? Other circumstances that the investigator considers inappropriate to participate in the trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T cell subsets;TCM syndrome score;

Secondary Outcome Measures

Name	Time	Method
Comorbidity rate;Opportunistic infection incidence and mortality;HIV/AIDS PRO Scale;HIV viral load;inflammatory markers;