Acquired Immune Deficiency Syndrome
Conditions
Interventions
Experimental group:The first stage: Albvirtide+Dolutegravir+Lamifudine
The second stage: Albvirtide+Dolutegravir
Sponsors
Chongqing Public Health Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected patients >=18 years, no gender limit; 2. Continued receiving ART for >=6 months; 3. HIV-1 RNA =6 months; 4. CD4+ T cell count >=200 /µL; 5. ESRD (CrCL=6 months before screening; 7. No history of drug resistance to Ebervirta, DTG and 3TC; 8. The patient of childbearing age and his or her partner agree to use recognized contraceptive methods; 9. The serum pregnancy test of women of childbearing age was negative at the time of enrollment; 10. Willing to cooperate with and able to participate in this study, including the use of intravenous drugs, complete all evaluations, and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. HBsAg is (+); 2. Lactation period; 3. Participate in clinical trials of other drugs within 30 days before enrollment; 4. Known allergy to the drugs or ingredients used in this study; 5. Severe cardiovascular disease, cancer, acute severe infection, severe liver injury, and other diseases that researchers have determined cannot be included; 6. In the investigator's opinion, there may be potential violations of study compliance or any other conditions affecting the evaluation of safety and efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The peak serum concentration of albuvirtide;The incidence of grade 3 or greater adverse events associated with therapeutic agents; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve for albuvirtide;The number of subjects with adverse events and serious adverse events;Percentage of subjects with HIV-1 RNA< 50 copies/mL;Change in CD4+T cell count from baseline;Change in creatinine clearance (CrCl) from baseline; | — |
Countries
China
Contacts
Public ContactChen Yaokai
Outcome results
None listed