HIV/AIDS patients with incomplete immune reconstitution
Conditions
Interventions
Test group:FNC+TDF+3TC+EFV, or FNC+TDF+3TC+LPV/r, or FNC+TDF+3TC+NVP, or FNC+AZT+3TC+EFV, or FNC+AZT+3TC+LPV/r, or FNC+AZT+3TC+NVP, or FNC+3TC+DTG
(Azvudine,FNC
Tenofovir Disoproxil Fumarate,TDF
Efavirenz,EFV
Lopinavir/ritonavir, LPV/r
nevirapine,NVP
zidovudine,AZT
lamividine,3TC
dolutegravir,DTG)
Sponsors
Pingmei Shenma Medical Group General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, either gender; 2.Confirmed HIV-1 infection; 3.Received antiretroviral therapy (ART) for at least 4 years with one of the following regimens: TDF + 3TC + EFV, TDF + 3TC + LPV/r, TDF + 3TC + NVP, AZT + 3TC + EFV, AZT + 3TC + LPV/r, AZT + 3TC + NVP, or 3TC + DTG; 4. The viral load in peripheral blood was continuously lower than the detection limit of<50 copies for at least 2 years, and the CD4+T cell count was<350/µ L; 5.No pregnancy plan in the near future and agrees to use effective non-pharmacological contraception during the study period and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.Participation in another clinical trial within 1 month prior to enrollment; 2.Receipt of immunomodulatory therapy within 1 month prior to enrollment; 3.Receiving a single-tablet regimen (STR) of ART; 4.ART regimen other than the following: TDF + 3TC + EFV, TDF + 3TC + LPV/r, TDF + 3TC + NVP, AZT + 3TC + EFV, AZT + 3TC + LPV/r, AZT + 3TC + NVP, or 3TC + DTG; 5.History of hypersensitivity or allergy to any ingredient or excipient of the study drug; 6.Presence of severe opportunistic infection or opportunistic neoplasm; 7.Positive hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (anti-HCV); 8.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >= 3 × upper limit of normal (ULN), or gamma-glutamyl transferase (GGT) >= 2.5 × ULN; 9.Hepatic insufficiency classified as Child-Pugh Class B or C; 10.Estimated glomerular filtration rate (eGFR) = ULN; 11.Presence of severe chronic diseases, metabolic diseases (e.g., diabetes mellitus), neurological or psychiatric disorders; 12.History of pancreatitis; 13.Pregnant or lactating women; 14.History of drug addiction, alcoholism, or substance abuse; 15.There are other reasons leading to long-term low CD4+T cell count, such as known types of immune deficiency or immunosuppression, chronic virus infection, blood tumor diseases, long-term use of immunosuppressive drugs, etc; 16.Other factors that make the subject ineligible for the trial, in the investigator's opinion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in the CD4+/CD8+ ratio following 48 weeks of treatment;The change from baseline in CD4+ T cell count following 48 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of subjects at 48 weeks post-administration; | — |
Countries
China
Contacts
Public ContactZhang Guodong
Pingmei Shenma Medical Group General Hospital
Outcome results
None listed