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Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. ANRS 135 Primeva

StatusCompleted
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v10

  2. Notable

    Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis to ANRS, Emerging Infectious Diseases

    Trial status: Active, Not Recruiting to Completed; Enrollment target: estimated 150 to confirmed 105; Study completion date changed from estimate of Sep 2013 to Nov 2012

    Study Identification, Study Status, Sponsor/Collaborators, Study Designv9

  3. Minor

    Completion date: Dec 2011 to Sep 2013

    Secondary endpoints: details revised at 1 of 6 entries

    Study Status, Sponsor/Collaborators, Outcome Measuresv8

  4. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Identification, Study Status, Contacts/Locationsv7

  5. Minor

    Secondary endpoints: 5 to 6

    Show what changed: Secondary endpoints
    Proportion of women with a VL below 50 copies per ml at delivery, Proportion of women harbouring resistant HIV strains four weeks after delivery, Concentrations of studied drug in plasma and in cord-blood, HIV-1 detection and concentrations of studied drug in vaginal secretion before and after treatment concentrations andof studied drugs in the new born gastric fluid, HIV diagnostic in infant (criteria for stopping the trial at second infection)

    Study Status, Outcome Measuresv6

Show 4 earlier versions

  1. Minor

    Interventions: Combivir (zidovudine/lamivudine) (Drug), Kaletra (lopinavir) (Drug) to Kaletra (lopinavir/ritonavir) (Drug), Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine) (Drug)

    Study arms: 0 to 2

    Study Status, Arms and Interventionsv5

  2. Minor

    Primary completion date: Sep 2011

    Completion date: Dec 2011

    Study Status, Sponsor/Collaboratorsv4

  3. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Site details revised

    Study Status, Oversight, Study Design, Contacts/Locationsv3

  4. Minor

    Study Status, Conditions

    Re-verified, no change to tracked fields

    v2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In the pre-partum phase the use of antiretroviral therapy for the mother during the last trimester of pregnancy is mandatory. The use of HAART during pregnancy, usually two nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate toxicities related to both families. The aim of this study is to assess the use of a boosted protease inhibitor without nucleoside analogue during the pre-partum phase for women with no indication of antiretroviral therapy for their own.
Trial Details
NCT Number NCT00424814
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: Abbott
Conditions HIV Infections
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov