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Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors

CompletedPhase 2

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: Maternal-fetal Infection Transmission

Interventions: darunavir monotherapy

Countries: France

The overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as treatment simplification (switch) in pretreated pregnant women, associated with neonatal prophylaxis with nevirapine, constituting a PMTCT strategy without any Nucleoside Reverse Transcriptase Inhibitor (NRTIs) .

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Locations (23)

Argenteuil, France
Bondy, France
Bordeaux, France
Bordeaux, France
Clamart, France
Colombes, France
Corbeil-Essonnes, France
Le Kremlin-Bicêtre, France
Lyon, France
Nantes, France
Nice, France
Paris, France
Paris, France
Paris, France
Paris, France
Paris, France
Paris, France
Paris, France
Paris, France
Perpignan, France
Rennes, France
Suresnes, France
Toulouse, France