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Early DOlutegravir/LAmivudine Switching after virological suppression (EDOLAS Study)
EU CTIS ID: 2024-518909-18-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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
You likely can't join if
- • 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.