Dolutegravir Plus Lamivudine Simplified Therapy

This study is an open-label, multicentered, single-arm and phase IV clinical trial. 300 HIV-infected patients who received simplified treatment regimen (50mg DTG+ 400mg 3TC, oral, qd) were selected to observe the treatment efficacy. At week 24, 36, 48 and 96, the rate of viral suppression and CD4 cell count were calculated against baseline. In addition, the safety and drug compliance were also monitored.

Inclusion criteria

• Age (> 18 years), male and female;
• HIV-1 infected;
• Using a standard three-drug-based regimen for at least 24 weeks. Based on clinical decision making* decide if patients can be treated with the DTG+3TC simplified scheme for a variety of reasons, such as (but not limited to): patients cannot tolerate the conventional three-drug treatment scheme, renal insufficiency, osteoporosis, bone marrow suppression and for other reasons patients cannot use the conventional three-drug treatment scheme;
• Initial HIV-1 RNA viral load and CD4 cell count were unlimited.
• CD4 can be monitored at least three times in the first year (including baseline, 24 weeks of treatment and 48 weeks of treatment). After the first year, CD4 can be detected at least once every six months.
• State Informed Consent for Free Treatment has been signed;
• Good compliance and signing Informed Consent

(* Reference criteria: Refer to APSIRE study, creatinine clearance rate (> 50 mL/min), no DTG/3TC allergy history, HBsAg negative, no chronic liver disease, no severe liver damage, no pregnancy during the study)

Exclusion criteria

• Has participated in other clinical trials of HIV vaccine or other drug trials in the past three months;
• Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.).
• Has a clear history of DTG or 3TC allergy;
• HBsAg and/or HBV-DNA positive;
• Pregnancy during the study period.