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HIV pill breakthrough: 4-Day week works as well as daily dosing

NCT ID NCT03256422

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether people with well-controlled HIV can safely take their antiretroviral drugs only 4 days in a row each week, instead of every day. Over 600 adults with stable HIV participated. The main goal was to see if the 4-day schedule kept the virus suppressed just as well as daily treatment. Results showed that the shorter schedule was non-inferior, meaning it worked nearly as well, potentially reducing pill burden and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

640 people

The number who actually took part.

Started

Sep 2017

Finished

Mar 2020

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HIV-1 infection, coinfection HIV-1/HIV-2 possible * Age≥18 years old * Current therapy unchanged for the last 4 months * Receiving tritherapy with 2 nucleoside reverse transcriptase inhibitor+protease inhibitors or 2 nucleoside reverse transcriptase inhibitor+non-nucleoside reverse transcriptase inhibitors or 2 nucleoside reverse transcriptase inhibitor+integrase inhibitors. Allowed treatment drugs are : 1\. nucleoside analogs : tenofovir (TDF ou TAF), emtricitabine, abacavir, lamivudine 2. protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r 3. Non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine 4. integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir * Viruses susceptible to all antiretroviral drugs present in the ongoing tritherapy (AC11-ANRS algorithm). 1. If a genotype is available in the patient medical history; viruses must be susceptible to all ongoing antiretroviral drugs 2. If no RNA genotype available, a genotype will be performed on DNA at screening and will not have to show any resistance to the ongoing antiretroviral drugs * Viral load (VL) \< 50 cp/mL in the past year, with at least 3 VL measurements including screening; only one episode of viral blip \< 200 copies/mL is authorized in the last year * CD4 T cells \> 250/mm3 at the screening visit * Estimated glomerular filtration rate \> 60 mL/min (Chronic Kidney Disease - Epidemiology Collaboration method) * Transaminases : aspartate aminotransférase et alanine aminotransférase \< 3N * Haemoglobin \> 10 g/dL * Platelets \> 100 000/mm3 * For women of childbearing age, negative pregnancy test at screening; agree to use mechanical contraception during the study * Social security system coverage * Informed consent form signed by patient and investigator Exclusion Criteria: * Infection by HIV-2 * Chronic and active Viral B Hepatitis with positive antigen HBs * Chronic and active Viral C Hepatitis with treatment expected in the next 98 weeks * Concomitant treatment using interferon, interleukins, any other immune-therapy or chemotherapy, antivitaminK for patients on ARVT using a booster * Concomitant prophylactic or curative treatment for an opportunistic infection * All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with study protocol compliance, observance and/or study treatment tolerance * Pregnant or breast feeding women * Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • Antoine Beclère

    Clamart, 92140, France

  • Avicenne

    Bobigny, 93000, France

  • Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • CHD de la Roche Sur Yon

    La Roche-sur-Yon, 85295, France

  • CHI de Créteil

    Créteil, 94010, France

  • CHRU Jean Minjoz

    Besançon, 25030, France

  • CHU Pointe-à-Pitre

    Pointe à Pitre, Guadeloupe, 97159, France

  • Centre Hospitalier Général de Saint Nazaire

    Saint-Nazaire, 44600, France

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges, 94195, France

  • Centre Hospitalier René Dubos

    Pontoise, 95301, France

  • Centre Hospitalier de Perpignan

    Perpignan, 66046, France

  • Centre Hospitalier de Saint-Brieuc

    Saint-Brieuc, 22000, France

  • Centre Hospitalier du Mans

    Le Mans, 72037, France

  • Centre hospitalier Annecy Genevois

    Pringy, 74374, France

  • Centre hospitalier Victor Dupouy

    Argenteuil, 95100, France

  • Centre hospitalier sud francilien

    Corbeil-Essonnes, 91106, France

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104, France

  • Hôpital André Mignot

    Versailles, 78157, France

  • Hôpital Bichat

    Paris, 75018, France

  • Hôpital Bretonneau

    Tours, 37044, France

  • Hôpital Carémeau

    Nîmes, 30029, France

  • Hôpital Civil

    Strasbourg, 67091, France

  • Hôpital Delafontaine

    Saint-Denis, 93205, France

  • Hôpital Dupuytren

    Limoges, 87042, France

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • Hôpital Emile Müller

    Mulhouse, France

  • Hôpital Européen

    Marseille, 13331, France

  • Hôpital Européen Georges Pompidou

    Paris, 75908, France

  • Hôpital Foch

    Suresnes, 92151, France

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • Hôpital Gui de Chauliac

    Montpellier, 34295, France

  • Hôpital Gustave Dron

    Tourcoing, 59208, France

  • Hôpital Henri Duffaut

    Avignon, 84000, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Hôpital La Grave

    Toulouse, 31059, France

  • Hôpital La Meynard Zobda Quitman

    Fort-de-France, Martinique, 97261, France

  • Hôpital Louis Pasteur

    Chartres, 28630, France

  • Hôpital Michallon

    Grenoble, 38043, France

  • Hôpital Necker

    Paris, 75015, France

  • Hôpital Nord

    Saint-Etienne, 42055, France

  • Hôpital Pellegrin

    Bordeaux, 33076, France

  • Hôpital Pitié-Salpêtrière

    Paris, 75651, France

  • Hôpital Pontchaillou

    Rennes, 35033, France

  • Hôpital Purpan

    Toulouse, 31059, France

  • Hôpital Raymond Poincaré

    Garches, 92380, France

  • Hôpital Robert Debré

    Reims, 51100, France

  • Hôpital Saint-André

    Bordeaux, 33075, France

  • Hôpital Saint-Antoine

    Paris, 75012, France

  • Hôpital Saint-Louis

    Paris, 75475, France

  • Hôpital Sainte Marguerite

    Marseille, 13274, France

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • Hôpital de La Source

    Orléans, 45100, France

  • Hôpital de l'Archet

    Nice, 06202, France

  • Hôpital de l'Hôtel Dieu

    Nantes, 44093, France

  • Hôpital de l'Hôtel Dieu

    Paris, 75181, France

  • Hôpital de la Croix Rousse

    Lyon, 69000, France

  • Hôpital de la Côte de Nacre

    Caen, 14033, France

  • Hôpital du Bocage

    Dijon, 21079, France

  • Hôtel-Dieu

    Paris, 75181, France

  • Institut hospitalier franco-britannique

    Levallois-Perret, 92309, France

  • Jean Verdier

    Bondy, 93143, France

  • Lariboisière

    Paris, 75475, France

  • Tenon

    Paris, 75970, France

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