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Study for prevention and treatment of AIDS patients with incomplete immune function reconstruction (liver and kidney essence deficiency syndrome) by kidney tonifying and medullating

Phase 1
Not yet recruiting
Conditions
AIDS
Registration Number
ITMCTR1900002485
Lead Sponsor
Hubei Provincial Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) HIV antibody was positive, confirmed by Western Blot;
(2) HAART>=12 months;
(3) CD4+T cell count increased by < 20% from baseline, or CD4+T cell count was still < 200 / mm3;
(4) HIV RNA < 50 copies /ml for one year;
(5) subjects aged between 18 and 65 years old, male or female;
(6) TCM syndrome differentiation belongs to the deficiency certificate of liver and kidney essence;
(7) voluntarily participate in this study, sign the informed consent, and follow up on time.

Exclusion Criteria

(1) before enrollment, severe opportunistic infections were not controlled (pneumocystis pneumoniae, meningitis, esophageal candida infection, lymphoma, toxoplasma encephalopathy, tuberculosis, etc.);
(2) patients who are participating in clinical trials of other drugs within one month before enrollment;
(3) those who received immunomodulator treatment within 1 month before enrollment;
(4) WBC < 2x10^9/L, N < 1.0x10^9/L, Hb < 90g/L, PLT < 75x10^9/L, hepatic and renal insufficiency (AST, ALT, t-bil >= 2 times the upper limit of reference value or creatinine detection >= 2 times the upper limit of reference value);
(5) patients with pancreatitis and active gastric ulcer;
(6) diseases of the active respiratory system, digestive system, circulatory system, blood system, neuroendocrine system and urogenital system of clinical significance;
(7) patients with autoimmune diseases;
(8) tumor patients requiring chemotherapy;
(9) pregnant or lactating women and women of childbearing age who do not use safe contraception;
(10) those with allergic conditions;
(11) patients with intellectual or language barriers who cannot fully understand the test content or give good cooperation;
(12) other circumstances considered unsuitable for participation in the study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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