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

Trial details

Who runs it

Societa Italiana Di Malattie Infettive E Tropicali SIMIT

Trial code

EU 2024-518909-18-00

Record updated

2026. május 8.

Original description

• To evaluate efficacy and safety of an early switch to a two-drug regimen with DTG/3TC as single pill in participants who achieved and maintained a recent (less than 1 year) virological suppression with a three-drug INSTI-based ART, compared to continuing the INSTI-based three-drug first-line regimen. The primary analysis will be performed on the intention-to-treat (ITT) population as the proportion of participants with virologic rebound (one HIV-1 RNA 50 copies/mL) at Week 48 as defined by the US Food and Drug Administration (FDA) snapshot algorithm (non-inferiority margin 4%). An exploratory interim analysis will be performed after 50% of participants have completed 24 weeks of follow-up. After 48 weeks all the participants actively followed in the control group will switch to DTG/3TC as single pill (delayed switch), and the final evaluation will be performed after 96 weeks.Read full original descriptionShow less

Efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) from INSTI-based three-drug regimens in HIV-1-infected adults previously naïve who achieve virological suppression

• To evaluate efficacy and safety of an early switch to a two-drug regimen with DTG/3TC as single pill in participants who achieved and maintained a recent (less than 1 year) virological suppression with a three-drug INSTI-based ART, compared to continuing the INSTI-based three-drug first-line regimen. The primary analysis will be performed on the intention-to-treat (ITT) population as the proportion of participants with virologic rebound (one HIV-1 RNA 50 copies/mL) at Week 48 as defined by the US Food and Drug Administration (FDA) snapshot algorithm (non-inferiority margin 4%). An exploratory interim analysis will be performed after 50% of participants have completed 24 weeks of follow-up. After 48 weeks all the participants actively followed in the control group will switch to DTG/3TC as single pill (delayed switch), and the final evaluation will be performed after 96 weeks.

Inclusion: 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.

Exclusion: 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.

EU CTIS 2024-518909-18-00