The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a 16 week induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor (INI) relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected antiretroviral therapy (ARV) naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cp/mL
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented HIV-1 infection (positive HIV-1 serology or plasma viral load)
* Age ≥ 18 years
* Therapeutic antiretroviral treatment-naive participant (history of prophylaxy is accepted)
* CD4 cells count \> 300 cells/mm3 at screening visit
* HIV-1-RNA plasma viral load \<50 000 copies/mL at screening visit
* Full susceptibility to trial drugs (NRTI, INI) at screening visit
* eGFR (epidermal growth factor receptor) \> 60 mL /min (MDRD)
* AST (aspartate aminotransferase), ALT(alanine transaminase) \< 3x norm
* Absence of any AIDS-defining event and/or opportunistic infection
* Possible contact by phone and/or email in order to be informed in case of detectable HIV plasma viral load
* Negative urinary pregnancy test at screening visit for women of childbearing age
* Written and informed consent signed
* For French participants only: subject enrolled in or a beneficiary of a Social Security programme (including State Medical Aid (AME), only if Ethic Committee approves it)
Exclusion Criteria:
* HIV-2 co-infection
* Hepatitis B Virus infection (positive HBs antigen)
* Any comorbidity potentially related to a life expectancy below 12 months
* Any condition (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
* Pregnant women or breastfeeding women
* Women of childbearing age that do not want to use an effective method of contraception
* Participant under justic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated early — can you tell me why it was stopped, and what that means for the safety or reliability of any data that was collected before it ended?
2The trial was testing a reduced or simplified antiretroviral treatment approach for HIV-1 — is that kind of strategy something worth considering in my own situation, or are there already approved regimens that achieve a similar goal?
3Since the study was aiming to show 'non-inferiority' at 48 weeks, meaning the new approach was meant to be no worse than standard treatment, does the fact that it was terminated before completion mean we simply don't know yet whether reducing antiretrovirals is safe long-term?
4Are there other active Phase 3 trials or approved treatment simplification options for HIV-1 that I should know about, given that this one is no longer enrolling?
5If reducing the number or dose of antiretrovirals was the goal here, what are the current risks and benefits of that approach based on evidence outside of this trial, and is it something my care team would ever consider for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To demonstrate at W48 the non-inferiority
Timeframe: proportion of participants with plasma HIV-RNA <50 copies/mL at Week 48 in the 2 arms on allocated treatment (FDA snapshot approach)