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

• Status: Completed
• Trial end date: 2020-07-16
• Target enrollment: 0
• Participant gender: Female

Summary

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) .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Darunavir; Reverse Transcriptase Inhibitors; Ritonavir

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)