Skip to content

Clinical efficacy evaluation and mechanism exploration of Haoqin Qingdan Granules in HIV / AIDS patients with incomplete immune reconstitution after antiretroviral therapy

Study on the thymus mechanism of artemisinin derivatives in HIV / AIDS patients with incomplete immune reconstitution after antiretroviral therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000019
Enrollment
Unknown
Registered
2023-06-24
Start date
2024-03-30
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immune Deficiency Syndrome

Interventions

Treatment group:Highly Active Antiretroviral Therapy and Haoqin Qingdan Granules
Control group:single Highly Active Antiretroviral Therapy

Sponsors

China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age range from 18 to 65 years old, regardless of gender; 2) HIV antibody positive, confirmed by Western Blot confirmation test; 3) Received Highly Active Antiretroviral Therapy for = 5 years and had a plasma HIV load of<50 copies/ml for more than 18 months; 4) The CD4+T lymphocyte count ranges between 200 cells/ul and 300 cells/ul; 5) Meets the diagnostic criteria for damp heat internal accumulation syndrome 6)Volunteer to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Severe Opportunistic infection was not controlled before enrollment; 2) Patients who participated in clinical trials of other drugs within one month prior to enrollment; 3) Individuals who received immunomodulatory therapy within one month prior to enrollment; 4) White Blood Cell < 2 × 109/L, Neutrophil count < 1.0 × 109/L, Hemoglobin < 90g/L, Platelet < 75 × 109/L, liver and kidney dysfunction (liver dysfunction refers to Aspartate transaminase , Alaninetransaminase, or total bilirubin = 2 times the upper limit of the reference value, and kidney dysfunction refers to creatinine clearance rate below the normal value) 5) Pregnant or lactating women, or women preparing for pregnancy; 6) Merge with other serious diseases (such as tumors, liver cirrhosis, cardiovascular and cerebrovascular diseases, etc.); 7) Patients with intellectual or language impairments who are unable to fully understand the experimental content or provide good cooperation.

Design outcomes

Primary

MeasureTime frame
T Cell Receptor Rearrangement Excision Circle;Immune reconstruction efficiency;

Secondary

MeasureTime frame
CD8+T lymphocytes;CD4+T lymphocytes;CD4+CD45RA+IL-7R;Tumor Necrosis Factor-a;Interleukin-7;Interleukin-2;T helper cell 17;clinical symptoms;Lipopolysaccharide;insulin-like growth factor 1;thymopoietin II; Interleukin-6;CD4+/CD8+ratio;Thymosin a;thymus index;growth hormone;CD4+CD25+CD45RO+;CD4+CD25+CD45RA+;

Countries

China

Contacts

Public ContactJipeng Dong,Jian Wang

China Academy of Chinese Medical Sciences

deeper-man@163.com15011481643

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026