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Evaluation Study of Clinical Efficacy of Incomplete Immune Reconstitution after ART for AIDS Based on Evidence-based Treatment

Evaluation Study of Clinical Efficacy of Incomplete Immune Reconstitution after ART for AIDS Based on Evidence-based Treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001016
Enrollment
Unknown
Registered
2025-05-21
Start date
2024-02-05
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Incomplete Immune Reconstitution after ART for AIDS

Interventions

Western Medicine Group:western medicine treatment
Chinese Medicine Practitioners Board:traditional chinese medicine treatment

Sponsors

Beijing Ditan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: - Duration of HARRT treatment =5 years plasma HIV load 12 months 2: Participants aged between 18 and 65 years both males and females are eligible 3: HIV-positive status confirmed by Western Blot assay 4: CD4+ T-lymphocyte count <350 cells/ul or an increase of <20% compared to the baseline count at the start of treatment 5: Compatible with deficiency syndrome excess syndrome or a combination of both according to Traditional Chinese Medicine (TCM) differential diagnosis. 6: Volunteers who are willing to participate in this study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1: CD4+T lymphocyte count > 350 cells/ul or > 20% increase from treatment baseline 2: Patients with severe opportunistic infections that were not controlled before enrollment 3: Patients who participated in other drug clinical trials within one month before enrollment or are currently participating 4: Patients who received immunomodulator therapy within one month before enrollment 5: Patients with WBC < 2×109/L N < 1.0×109/L Hb < 90g/L PLT < 75×109/L abnormal liver or kidney function (abnormal liver function refers to AST or ALT or T-BIL = 2 times the upper limit of the reference value and abnormal kidney function refers to creatinine clearance rate below normal) 6: Women who are pregnant or breastfeeding or women planning to become pregnant 7: Patients with other severe comorbidities (such as cancer liver cirrhosis cardiovascular and cerebrovascular diseases etc.) 8: Patients with intellectual or language disabilities who cannot fully understand the trial content or provide good cooperation

Design outcomes

Secondary

MeasureTime frame
helper T cell subsets;Viral Load: HIV-RNA or HIV-DNA;World Health Organization Quality of Life Scale;

Primary

MeasureTime frame
Immunological index;

Countries

China

Contacts

Public Contactlixin

Beijing Ditan Hospital Capital Medical University

leaxin@sina.com13910908996

Outcome results

None listed

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