AIDS
Conditions
Interventions
Treatment group:Albuvirtide administered 640mg per four weeks for 24 weeks in combination therapy with ART therapy for 36 weeks
Control group:Keep on the original ART therapy for 36 weeks
Sponsors
WUHAN JINYINTAN HOSPITAL(Wuhan Infectious Disease Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Chinese subjects aged 18-65 years (inclusive), regardless of gender; 2) Diagnosed with HIV/AIDS; 3) On antiretroviral therapy (ART) for more than 1 year; the ART regimen (excluding albuvirtide) has been used continuously for more than 3 months at the time of screening, and previous regimen or drug changes were not due to virologic failure (switching between individual antiretroviral drugs of the same class is not considered a change in the ART regimen); 4) Plasma HIV-1 RNA < 50 copies/mL at the time of screening; 5) CD4+ T lymphocyte count has increased by < 50 cells/µL compared to 6 months ago and the absolute CD4+ T lymphocyte count is < 500 cells/µL; 6) Willing to voluntarily sign the informed consent form and able to ensure follow-up.
Exclusion criteria
Exclusion criteria: 1) Used a gp41-targeted fusion inhibitor in the past 6 months; 2) Present with (as defined by national AIDS treatment guidelines) opportunistic infections or AIDS-related malignancies at the time of enrollment; patients who have had opportunistic infections in the past 6 months but are considered stable for less than 14 days by the investigator; 3) Results detected during the screening period: hemoglobin 1.5 times the upper limit of normal, aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline phosphatase > 3 times the upper limit of normal, total bilirubin > 2 times the upper limit of normal; 4)Pregnant or breastfeeding women; 5) Individuals with plans to conceive; 6) Current drug users; 7) Used other immunomodulators or plan to use such products in the past 6 months (immunomodulators such as cyclosporin A, glucocorticoids, hydroxyurea, chloroquine, hydroxychloroquine, interleukins, thymosins, vaccines, probiotics, etc.); 8) Other conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in CD4+T lymphocyte count compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in CD4+T lymphocyte count compared to baseline;Virus load inhibition ratio;CD4+T lymphocyte count change ratio from baseline;Proportion of subjects with CD4+T lymphocyte count increase greater than 50; ? ?Changes in CD4+T lymphocyte/CD8+T lymphocyte ratio compared to baseline;New incidence of AIDS related diseases; | — |
Countries
China
Contacts
Public ContactLianguo Ruan
WUHAN JINYINTAN HOSPITAL(Wuhan Infectious Disease Hospital)
Outcome results
None listed