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HIV treatment showdown: could simpler drug regimens reduce inflammation?

NCT ID NCT05699785

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nice 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at HIV patients over 40 (or those on HIV therapy for over 10 years) who switched to either a three-drug or a two-drug antiretroviral regimen. Researchers will measure markers of inflammation in the blood and track how many patients develop other health conditions over three years. The goal is to see if a simpler, two-drug therapy leads to less inflammation and fewer comorbidities than the standard three-drug approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir/lamivudine)
What this could lead to
If successful, this could help doctors choose the best HIV treatment regimen to reduce long-term inflammation and lower the risk of other health problems.
What could go wrong
This is an observational study, not a controlled trial, so it can show links but not prove cause and effect. Results may not apply to all HIV patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 * Age \> 40 years or adults with more than 10 years of antiretroviral therapy * Switching to BIC/FTC/TAF or DTG/3TC or DTG+3TC within the last 2 years * Plasma HIV-1 RNA viral load \< 50 copies/ml for more than 6 months * Absence of chronic hepatitis B infection * Absence of genotype mutations on Dolutegravir (DTG) or Bictegravir (BIC) or tenofovir alafenamide TAF * Daily use of antiretroviral therapy * Effective contraception for women of childbearing potential will be requested * Signed informed consent * Enrollment in a Social Security plan Exclusion Criteria: * Non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week) * Pregnancy or breastfeeding * Vulnerable persons according to article L.1121-6 of the public health code Persons unable to give consent according to article L.1121-8 of the public health code * Opportunistic infections during curative treatment * HIV-2 infection * Active hepatitis C * Refusal to participate * Withdrawal of informed consent by the patient

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

HIV

Contacts and locations

Locations

  • CH Simone VEIL

    Cannes, 06614, France

  • CHU Nice

    Nice, France

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