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Clearance of Viral Reservoirs in Individuals with Acute HIV Infection Through Combined Interferon and Antiretroviral Therapy: A Randomized, Open-Label, Parallel-Controlled Clinical Study

Clearance of Viral Reservoirs in Individuals with Acute HIV Infection Through Combined Interferon and Antiretroviral Therapy: A Randomized, Open-Label, Parallel-Controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100011
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Acute HIV infection

Interventions

Peg-IFN combined with ART group:Peg-IFN combined with ART regimen treatment.
ART group:either DTG or BIC-based ART regimen

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for acute HIV infection as defined in the Guidelines for Diagnosis and Treatment of HIV/AIDS in China (2024 Edition); 2.Aged between 18 and 60 years; 3.No prior anti-HIV therapy; 4.Capable of providing written informed consent and willing to voluntarily participate in this clinical study;

Exclusion criteria

Exclusion criteria: 1.Patients with co-infection of viral hepatitis; 2.Patients with a history of or current diagnosis of liver cirrhosis or hepatocellular carcinoma; 3. Pregnant or breastfeeding women, or those planning to conceive in the near future; 4. Patients with a history of severe cardiac diseases, including unstable or uncontrolled cardiac conditions within the past 6 months; 5. Patients with uncontrolled diabetes, hypertension, thyroid disorders, retinopathy, clinically significant ophthalmologic conditions, autoimmune diseases, epilepsy, or other similar conditions; 6.Laboratory findings meeting any of the following criteria: • Neutrophil count 10 × ULN, or total bilirubin > 34 µmol/L; 7. Patients with opportunistic infections associated with HIV; 8. Patients with malignant tumors or contraindications to interferon therapy (e.g., interferon allergy, severe pulmonary diseases); 9.Patients with a history of psychiatric disorders; 10. Patients with a history of alcoholism, substance abuse, or drug misuse; 11. Any other condition that, in the opinion of the investigator, deems the patient unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Percentage decrease in HIV DNA after 48 weeks of treatment.;

Secondary

MeasureTime frame
Percentage decrease in HIV DNA after 12 weeks of treatment.;CD4+ T cell growth rates at 12 and 48 weeks of treatment;Cytokine levels;inhibition rate of HIV RNA;Adverse event rate;

Countries

China

Contacts

Public ContactZhang Tong

Beijing Youan Hospital, Capital Medical University

zt_doc@163.com+86 10 83997162

Outcome results

None listed

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