HIV-1 infection / AIDS-related condition: most participants are chronically HIV-infected individuals with virological suppression on ART. Potential related manifestations include impaired immune function (e.g., changes in CD4 count), increased risk of opportunistic infections, and systemic symptoms such as fatigue, weight loss, fever, diarrhea, and rash. This study primarily focuses on virological
Conditions
Interventions
PEG-IFNa-2b + ABT + background ART group (single-arm):Pegylated interferona-2b + albuvirtide (ABT) with background antiretroviral therapy (ART)
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for HIV infection according to the Chinese HIV/AIDS Diagnosis and Treatment Guidelines (2024 edition), and have been on antiretroviral therapy (ART) for > 1 year prior to enrollment. 2. Aged 18–50 years (inclusive), either sex. 3. Body mass index (BMI) >= 18 kg/m^²; body weight >= 50 kg for males and >= 45 kg for females. 4.Screening HIV-1 RNA = 500 cells/µL. 6. Normal electrocardiogram (ECG) and normal thyroid function. 7. Willing to participate in the trial, able to understand the study, and provides written informed consent voluntarily. 8.The participant and their partner have no plans for conception during the study period and agree to use effective non-pharmacological contraception throughout the study. 9) Screening period hemoglobin (Hb) >= 100 g/L, platelet count (PLT) >= 90×10^9/L; absolute neutrophil count (ANC) > 1.0×10^9/L; prothrombin activity (PTA) > 60%; serum creatinine < 1.5× ULN; ALT < 10× ULN; total bilirubin (TBIL) < 3× ULN.
Exclusion criteria
Exclusion criteria: 1.History of allergy or hypersensitivity to albuvirtide (ABT) or interferon products. 2.Current use of, or use within the past 6 months of, fusion inhibitors such as ABT, LP80, LP98, etc. 3.Receipt of immunosuppressants or other immunomodulatory agents (e.g., thymosin) or systemic cytotoxic therapy within 6 months prior to screening. 4.Confirmed diagnosis of another type of immunodeficiency. 5.Vaccination within 6 weeks prior to screening or planned vaccination within the next 6 months. 6. Individuals with neuropsychiatric disorders, especially those with a history of mental illnesses such as depression, anxiety, mania, schizophrenia, or a family history of mental disorders (particularly a history of depression or depressive tendencies); 7. Antinuclear antibody (ANA) titer >= 1:1000. 8. Individuals co-infected with HAV, HCV, HDV, or HEV; 9. Chronic liver diseases caused by other reasons, such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease; decompensated cirrhosis; malignant tumors and severe cardiopulmonary diseases (especially heart disease that has been unstable or poorly controlled within the past 6 months); acute/chronic nephritis, renal insufficiency, nephrotic syndrome; poorly controlled hypertension or diabetes; uncontrollable epileptic seizures; severe cerebrovascular diseases; severe gastrointestinal disorders; currently active pulmonary tuberculosis undergoing treatment; autoimmune diseases (including psoriasis and systemic lupus erythematosus); endocrine system disorders, including thyroid diseases; women who are pregnant or breastfeeding; 10. Individuals with severe retinal lesions or other serious ophthalmic diseases; 11. Those with other major organ structural lesions or dysfunction; 12. Individuals planning to undergo or who have already undergone organ transplantation; 13. Blood phosphorus < 0.8 mmol/L; 14. History of alcohol abuse or drug abuse; 15. Participation in other clinical trials within the 3 months prior to screening; 16. Any other conditions that the investigator considers incompatible with participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who do not meet ART restart criteria at Week 12 after treatment interruption; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who do not meet ART restart criteria at Week 24, 48 and 96 after treatment interruption; | — |
Countries
China
Contacts
Public ContactJiang Taiyi
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed