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Could a lower HIV drug dose work just as well?

NCT ID NCT02384967

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether a lower daily dose of the HIV drug darunavir (400 mg instead of 800 mg) can keep the virus suppressed in people whose HIV is already well-controlled. The trial involved 100 adults with HIV who had undetectable viral loads for at least a year. The goal was to see if the reduced dose could maintain viral suppression for 48 weeks.

What this could mean

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

Active substance
darunavir (a lower dose of 400 mg per day instead of the usual 800 mg)
What this could lead to
If successful, this could allow some people with HIV to take a lower dose of darunavir while still keeping the virus under control, potentially reducing side effects and costs.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 100 participants. It is not yet proven that the lower dose works as well as the standard dose, and there is a risk of the virus becoming detectable again.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Mar 2015

Finished

Oct 2016

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 infected adults, * age ≥ 18 years, * with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months), * virologically controlled (VL ≤ 50 cp/ml, * ≥ 1 year, * at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count ≥ 300/mm3 ≥ 6 months, * virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and * with no history of virological failure (VL \> 200 cp/mL after ≥ 6 months under PI and/or used NRTI), * no current opportunistic infection, * renal clearance ≥ 60 mL/min if tenofovir is used, * transaminases (SGOT, SGPT) plasma levels \< 2N, * hemoglobin \> 11 g/dL, * platelets count \> 150 000/mm3, * negative pregnancy test in women with childbearing potential, * informed written consent signed by both the investigator and the subject, * national insurance scheme (article L1121-11 of the French Public Health code), * no participation to any other clinical trial Exclusion Criteria: * HIV-2 infection, * current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI, * virus genotypically resistant to darunavir and the used NRTIs, * history of virological failure (VL \> 200 cp/mL after ≥ 6 months under PI and/or used NRTI), * irregular follow-up and/or history of lack of adherence to ART ≤ 12 months, * current pregnancy, * current opportunistic infection, * associated treatment containing one or more drugs interacting with hepatic cytochromes, * any addictive behaviors (alcohol consumption, drugs …) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.

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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 infection

Contacts and locations

Locations

  • Hôpital Saint Louis

    Paris, 75010, France

More trials for these conditions

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