Early DOlutegravir/LAmivudine Switching after virological suppression (EDOLAS Study)

Lab values

• Having failed virologically • Having changed the INSTI drug • Any major INSTI- or NRTI-resistance-associated mutation documented before starting ART • Pregnancy or breast-feeding • HBsAg positivity • HCV-RNA positivity needing for any hepatitis C virus (HCV) therapy during the study • An active malignancy or opportunistic infection requiring active treatment • Women of childbearing potential not adopting an effective birth control system throughout the study period • Creatinine clearance of <50 mL/min/1.73m2 via CKD-EPI method • A life expectancy <2 years • Use of HIV immunotherapeutic vaccines; other experimental agents, ART drugs not otherwise specified in the protocol, cytotoxic chemotherapy, systemically administered immunomodulators • Individuals who in the investigator’s judgment, poses a significant suicidality risk; • Major Depression, Bipolar Disorders and Psychoses

• HIV-1 documented infection • Age 18 years • To be treated as ART naïve for overall less than 18 months before screening/baseline • To receive a stable (not changed) INSTI-based first-line three-drug ART (see Target Population section for regimens allowed); switch between different NRTIs are allowed • To have reached a HIV-1 RNA <50 copies/mL during INSTI first-line therapy for less than 12 months. At least a single HIV-1 RNA determination below the threshold within the 6 months before enrollment is required (if a following determination in present, this should not be 50 copies (cp)/mL) • Evidence of HbsAg negative less than 18 months before screening/baseline • No known allergy or intolerance to NRTIs, or INSTIs • Being able to comply with the protocol requirements • Informed consent signed