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The clinical effects of artesunate on immune reconstruction for immunologic non-responders of ART-treated HIV/AIDS patients: a randomized controlled trial

The clinical effects of artesunate on immune reconstruction for immunologic non-responders of ART-treated HIV/AIDS patients: a randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043675
Enrollment
Unknown
Registered
2021-02-26
Start date
2021-02-20
Completion date
Unknown
Last updated
2021-06-22

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:HAART+artesunate tablets
control group:HAART+artesunate tablet simulation agent

Sponsors

China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Male or female patients aged from 40 to 65years old; 2) positive test for HIV antibody confirmed by Western blot?assay; 3) less than five-year treatment of HAART, and plasma HIV viral load less than 50 copies/mL for more than 18 months; 4) CD4+T lymphocyte count between 200 cells/uL and 300 cells/uL; 5) Consent to participate in this study with signed informed consent.

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows. 1) Uncontrolled severe opportunistic infection prior to?enrollment; 2) Participating in other clinical trial within a month?prior to enrollment; 3) Receiving immunomodulator within a month; 4) WBC = 2 times of the upper limit of reference value) or kidney dysfunction (lower creatinine clearance rate); 5) Pregnant or lactating women, or women preparing for pregnancy; 6) Combined with other serious diseases (such as tumor, liver cirrhosis, cardiovascular and cerebrovascular diseases, etc.; 7) with mental or language impairment and difficulty in fully understanding the trial or failing to cooperate.

Design outcomes

Primary

MeasureTime frame
Absolute Value of CD4+ cells;Immune Reconstruction Efficiency;

Secondary

MeasureTime frame
CD8+, CD45RA+, CD45RO+, CD4+CD28+, CD8+CD38+, CD4+CD38+;Cell proliferation and apoptosis: CD4+ki67+/CD4+, CD8+ki67+/CD8+, mitochondrial membrane potential;clinical symptoms;Viral load;

Countries

China

Contacts

Public ContactWang Jian

China Academy of Chinese Medical Sciences

62tiger@163.com+86 010-64039230

Outcome results

None listed

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