HIV/AIDS
Conditions
Interventions
Experimental group:HAART+ Qirong Fuzheng Mixture 4 times/day, 30mL/ times, once in the morning, in the afternoon, in the evening and before going to bed
Placebo control group:HAART+ Qirong Fuzheng Mixture simulator 4 times/day, 30mL/ time, once in the morning, in the afternoon, in the evening and before going to bed
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Have been diagnosed with HIV infection (refer to the Chinese AIDS Diagnosis and Treatment Guidelines (2021 edition)) ; 2. Patients with HAART treatment duration =24 months and maintaining the current HAART treatment duration =6 months, without changing the treatment regimen during the study period; 3.HIV viral load is lower than the lower limit of detection (< 50 copies/ml); 4.CD4+T lymphocyte count 100-350 /µL; 5.18 years old = age =70 years old, gender is not limited; 6. Patients with spleen-kidney Yang deficiency and (or) Qi deficiency and blood stasis syndrome of traditional Chinese medicine; 7. Participate in the trial voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe opportunistic infections, including pneumocystis pneumonia (PCP), active tuberculosis, non-tuberculous mycobacterium infection, active cytomegalovirus (CMV) infection, toxoplasmosis encephalopathy, deep fungal infections (e.g., cryptococcal meningitis or meningoencephalitis, Marneffei basket disease, etc.), septicemia, And combined with AIDS-related tumors such as non-Hodgkin lymphoma, Kaposi's sarcoma, etc. 2. Patients with severe cardiovascular and cerebrovascular, respiratory, liver and renal insufficiency (ALT, AST= 2.5 times of the upper limit of normal, TBiL= 2 times of the upper limit of normal, Scr= normal), blood or mental and nervous system diseases; 3. Diabetic patients with poor glycemic control (defined as 7.5%=HbA1C, effective results within 6 weeks before screening); 4. Patients who are allergic or allergic to any known component of the drug in this study; 5. Pregnant or lactating women; Or women with reproductive potential who do not use contraception considered effective by researchers (e.g., diaphragm; Condoms; Intrauterine devices; Partner vasectomy or abstinence), female subjects who did not wish to continue using investigator-approved contraceptive methods for 3 months after screening until the last time they took the test drug. Male subjects with active heterosexual sex who have not undergone vasectomy, who are not using birth control, or who do not wish to continue using contraception during the trial period and for at least 3 months after the trial ends; 6. A history of alcoholism that cannot be terminated (drinking =14 units of alcohol per week: 1 unit = 285mL for beer, 25mL for spirits, or 150mL for wine); 7. People with a history of drug abuse; 8. Participants who have participated in other clinical trials and used the corresponding experimental drugs, devices or therapies within 3 months before signing the informed consent; 9. Other patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CD4+ cell count from baseline at 24 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of CD4+ cell count from baseline at 12 and 18 weeks of treatment and response rate at 24 weeks of treatment;Clinical effect of TCM syndrome score for 24 weeks;Change value of TCM syndrome score from baseline at 4, 12, 18 and 24 weeks of treatment;The number of CD8+ cells changed from baseline at 12, 18, and 24 weeks of treatment;CD4+ cell /CD8+ cell ratio change from baseline at 12, 18, and 24 weeks of treatment;Change of HIV viral load from baseline at 12 and 24 weeks of treatment;Changes in individual symptom scores from baseline at 4, 12, 18, and 24 weeks of treatment;HIV/AIDS patients at 12 and 24 weeks of treatment reported changes in outcome rating scale scores from baseline;Change of World Health Organization Quality of Life Scale (Chinese version) score from baseline after 12 and 24 weeks of treatment; | — |
Countries
China
Contacts
Public ContactLu Hongzhou
The Third People's Hospital of Shenzhen
Outcome results
None listed