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

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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. 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
    v9
  3. Study completion date: Dec 2011 to Sep 2013
    • Secondary endpoints: details revised at 1 of 6 entries
    v8
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  5. Secondary endpoints: 5 to 6v6
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  1. 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
    v5
  2. Primary completion date: Sep 2011
    • Study completion date: Dec 2011
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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
(from sponsor)		 HIV Infections
Related terms HIV Infections
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov