HIV
Conditions
Interventions
Treatment group:Albuvirtide and dolutegravir
Sponsors
Chongqing Public Health Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Over 18 years old; 2.Confirmed to be HIV-1 infected; 3.With end-stage renal disease (ESRD) undergoing stable hemodialysis at designated centers 2 to 3 times per week; 4.Serum creatinine clearance CrCl 200 cells/µL; 9.Persons of childbearing age and their partners agree to adopt recognized contraceptive measures; 10.Female of childbearing age with negative results of serum pregnancy test; 11.Willing to cooperate and be able to participate in this study, including the use of intravenous drugs, completing all evaluations, and signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Female who are pregnant, breastfeeding or planning to become pregnant; 2.History of allergy to oral medications or injections; 3.Participating in other clinical trials within 30 days prior to enrollment; 4.Allergy to or having anti-drug antibodies to the drugs or excipients used in this study; 5.Upon the investigator's determination, the subject has any potential circumstance negatively impacting on treatment adherence, safety and effecacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extraction rate of albuvirtide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Extraction rate of dolutegravir;Percentage of subjects with HIV-1 RNA <50 copies/mL after treatment;Change of CD4+ cell count from baseline after treatment;Change of creatinine clearance (CrCl) from baseline after treatment; | — |
Countries
China
Contacts
Public ContactChen Yaokai
Chongqing Public Health Medical Center
Outcome results
None listed