HIV/AIDS
Conditions
Interventions
Research group:Albuvirtide combined with original ART regimen
Sponsors
Guangzhou Eighth Peoples Hospital Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Chinese study participants aged 18-65 years, regardless of sex; 2.Confirmed diagnosis of HIV-1 infection; 3.Diagnosis as an immunological non-responder; (1) Participants must have been stably receiving ART for more than 4 years before screening, using their current ART regimen (excluding ABT) for more than 6 months, and the previous regimen or drug switch was not due to virological failure; The following single antiretroviral drug switches are not considered a change in ART regimen: a) Switching between Lamivudine (3TC) and Emtricitabine (FTC) (and vice versa) b) Switching between Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) (and vice versa) (2) Participants should provide at least 2 plasma HIV-1 RNA test results =1000 copies/mL within the past 3 years, nor two consecutive tests with 50 copies/mL =3 months within 12 months prior to screening (the second test may use the screening period result), and there should be no CD4 T-lymphocyte count >=350 cells/µL within those 12 months; (4) At screening, participants should have plasma HIV-1 RNA <50 copies/mL and CD4 T-lymphocyte count <350 cells/µL. 4.Voluntary provision of written informed consent and ability to guarantee follow-up attendance;
Exclusion criteria
Exclusion criteria: 1.Current use or use within the 3 months prior to screening of a fusion inhibitor targeting gp41; 2.Presence of AIDS-related opportunistic infections or AIDS-defining malignancies at screening; 3.Detection of any of the following laboratory abnormalities during the screening period: hemoglobin 1.5 times the upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >3 × ULN, total bilirubin >2 × ULN; 4.Pregnant or lactating women; 5.Women planning pregnancy who are unable to comply with required contraceptive measures; 6.Current illicit drug users; 7.Use of other immunomodulators within the past 6 months or planned use of such products during the study (immunomodulators include, but are not limited to, cyclosporine A, glucocorticoids, hydroxyurea, chloroquine, hydroxychloroquine, interleukins, thymosin, vaccines, probiotics, etc.); 8.Any other condition deemed by the investigator to be unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CD4 T lymphocyte count from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of viral load suppression;Blood lipid levels; | — |
Countries
China
Contacts
Public ContactLi Linghua
Guangzhou Eighth Peoples Hospital Guangzhou Medical University
Outcome results
None listed