AIDS
Conditions
Interventions
study group:3TC+DTG
control group:EVG/c/TAF/FTC
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) PLWH irrespective of gender, aged 18-75 years; (2) A female may be eligible to enter and participate in the study if she: 1) Lack of fertility, defined as postmenopausal (spontaneous amenorrhea within 12 months, >= 45 years old) or physical inability to conceive after tubal ligation, hysterectomy or bilateral oophorectomy; 2) fertile, but is negative on screening and day 1 pregnancy test, and agrees to use appropriate contraceptive methods, including oral contraceptives, condoms and iUDs,etc. (3) At least once plasma HIV-1 RNA = 6 months prior to screening; (5) Sign the informed consent and be able to visit regularly according to the test requirements.
Exclusion criteria
Exclusion criteria: (1) Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study; (2) Participants with AIDS-related opportunistic infections or AIDS-related or unrelated neoplastic diseases; (3) Patients with ALT >= 5 x ULN, or ALT >=3 x ULN and bilirubin >= 1.5 x ULN (with > 35% direct bilirubin. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (4) Evidence of Hepatitis B virus (HBV) infection: Participants positive for HBsAg, negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. (5) Hepatitis C virus (HCV) infection; (6) Participants who are allergic or intolerant to lamivudine or dolutegravir; (7) Participants with known previous episodes of virologic failure and known resistance mutations of 3TC or INSTI if resistance mutations had previously been identified; (8) Taking medications that contraindicated with lamivudine or dolutegravir; (9) Participants with creatinine clearance < 30ml/min. (10) Other conditions that the investigator considers unsuitable to participate in the study, including the risk of suicide, poor adherence, and interfeirence with the evaluation of clinical study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage of participants with virologic failure after 48 weeks of treatment ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from Baseline in CD4+ Cell Counts at Week 24 and 48;Change from Baseline in renal and bone biomarkers at Weeks 24, 48; | — |
Countries
China
Contacts
Public ContactRenfang Zhang
Shanghai Public Health Clinical Center
Outcome results
None listed