AIDS
Conditions
Interventions
Experimental group:Background entry regimen + albuvirtide 320mg ivgtt
Control group:Background entry regimen
Sponsors
Tianjin Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged 18-65 (including cut-off value) years, male or female; 2. HIV Infection; 3. Being receiving antiretroviral therapy; 4. The CD4+ T cell count of patients: less than 500 cells/uL for 5 years of ART; less than 200 cells/uL for 2-5 years of ART (result within 1 month before enrollment); 5. Viral load less than 50 copies/mL (results within 1 month); 6. Willing to provide informed consent and guarantee follow-up; 7. No plan to move away from the current site during the trial.
Exclusion criteria
Exclusion criteria: 1. Prior exposure to fusion inhibitors targeting gp41; 2. Opportunistic infections or AIDS-related malignancies (as defined in Chinese guidelines for diagnosis and treatment of HIV/AIDS [2021 edition]) prior to study entry; opportunistic infections 6 months prior to study entry, but the investigator believes that the condition is stable for more than 14 days; 3. Screening as one of follows: hemoglobin 1.5 x ULN, aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase > 3 x ULN, total bilirubin > 2 x ULN; 4. Pregnant or breastfeeding women; 5. Those who have a birth plan; 6. Drug abuse; 7. Severe mental neurological diseases; 8. Those who have a history of alcohol abuse and cannot be terminated; 9. Severe peptic ulcer; 10. Acute hepatitis; 11. Acute and chronic pancreatitis; 12. Other diseases, in the judgment of the investigator, are not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The CD4+ T cell count; | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV-1 RNA level; | — |
Countries
China
Contacts
Public ContactMa Ping
Tianjin Second People's Hospital
Outcome results
None listed