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HIV drug showdown: which strategy works best for new patients?

NCT ID NCT04051970

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 compared two HIV treatment approaches in people who had never taken HIV drugs before. One group started with a three-drug combo for 16 weeks, then switched to a two-drug combo. The other group took a two-drug combo from the start. The goal was to see if the first approach worked just as well after 48 weeks. The study was stopped early, so results are limited.

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

360 people

The number who actually took part.

Started

Nov 2019

Finished

Dec 2022

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: * 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 justice protection * Galactose/lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (known or documented) * Participation to another clinical trial evaluating a new treatment/therapy

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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-1-infection

Contacts and locations

Locations

  • Hôpital la Salpêtrière

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.