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New HIV prevention strategy for pregnant women could eliminate need for common drugs

NCT ID NCT02738502

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a single HIV drug, darunavir/ritonavir, could replace the usual combination therapy in pregnant women with well-controlled HIV. The goal was to prevent mother-to-child transmission without using a class of drugs called NRTIs. 91 pregnant women already on HIV treatment and with undetectable virus levels participated. The approach aims to simplify treatment while keeping the baby safe.

What this could mean

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

Active substance
darunavir/ritonavir (DRV/r) monotherapy
What this could lead to
If successful, this could offer a simpler, NRTI-free treatment option for pregnant women with HIV to prevent mother-to-child transmission.
What could go wrong
This is a small, early-phase pilot study with only 91 participants, so results may not apply broadly. The monotherapy may fail to keep viral load suppressed, risking transmission.

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

91 people

The number who actually took part.

Started

Jul 2016

Finished

Jul 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

Female participants only

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: * Pregnant woman, under 15 weeks gestational age at screening * Documented Human Immunodeficiency Virus (HIV) HIV-1 infection (serology and/or plasma HIV RNA viral load) * Current treatment with at least two ARVs * Virological suppression for at least 12 months, defined by a PVL \< 50 copies / mL. A blip (transiently ≥ 50 but \< 400 copies/mL) will not be considered as an exclusion criterion, if it is followed by 2 successive controls with CV \< 50 at least one month before enrollment * Plasma viral load \< 50 copies/mL at pre-inclusion * CD4 ≥ 250 cells/mm3 at pre-inclusion * Informed written consent * Health care coverage Inclusion criteria for the child : * Mother enrolled in the trial * Informed written consent by parents or legal guardians Exclusion Criteria: * Infection by HIV-2 * History of treatment failure and/or resistance with any Protease Inhibitor (PI). Treatment failure is defined by a viral replication (≥ 50 copies/mL) during antiretroviral treatment. An increasing CV due to treatment interruption will not be considered as a failure, providing that the absence of resistance mutations to at least one PI can be confirmed by genotyping. * Documented CD4 lymphocyte less than 200/mm3 * Known intolerance to darunavir or ritonavir * Hepatitis B Virus (HBV) co-infection (HBs Ag-positive and/or detectable HBV DNA) on therapy with analogs (tenofovir, emtricitabine, lamivudine) * Known resistance of maternal viral strain to darunavir or nevirapine * Intended absence (travel abroad, moving ...) * Expected delivery in a maternity hospital not participating in the trial * Participation in the trial during previous pregnancy * Persons under guardianship or deprived of liberty by a judicial or administrative decision Exclusion criteria for the child: * Refusal by parent (s) or legal guardian (s)

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Conditions

The condition(s) this trial relates to.

HIV infectious disease congenital human immunodeficiency virus prevention target

As listed by the trial registrant

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

Maternal-fetal infection transmission

Contacts and locations

Locations

  • CH Victor Dupouy

    Argenteuil, 95100, France

  • CHU Archet 1

    Nice, 06202, France

  • CHU Rennes Hôpital Pontchaillou

    Rennes, 35000, France

  • CHU Toulouse

    Toulouse, 31059, France

  • CHU de Perpignan

    Perpignan, 66046, France

  • Groupe hospitalier Cochin-Broca- Hôtel Dieu

    Paris, 75014, France

  • Groupe hospitalier Pellegrin

    Bordeaux, 33000, France

  • HEGP

    Paris, 75015, France

  • Hôpital Antoine Béclère

    Clamart, 92140, France

  • Hôpital Armand Trousseau

    Paris, 75012, France

  • Hôpital Bichat - Claude Bernard

    Paris, 75018, France

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • Hôpital Foch

    Suresnes, 92151, France

  • Hôpital Jean Verdier

    Bondy, 93140, France

  • Hôpital Lariboisiere

    Paris, 75010, France

  • Hôpital Louis Mourier

    Colombes, 92700, France

  • Hôpital Necker Enfant malades

    Paris, 75015, France

  • Hôpital Saint André

    Bordeaux, 33075, France

  • Hôpital Sud Francilien

    Corbeil-Essonnes, 91106, France

  • Hôpital Tenon

    Paris, 75020, France

  • Hôpital de la croix Rousse

    Lyon, 69307, France

  • Hôpital la Pitié Salpétrière

    Paris, 75013, France

  • Hôtel Dieu

    Nantes, 44093, France