Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vertical infection transmission
  • Age: Between 18 - 100 Years
  • Gender: Female

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 and history of CD4 count nadir > 200/mm3
  • 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)
  • 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 ...)
  • 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)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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