Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. ANRS 135 Primeva
2 other identifiers
interventional
105
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
Started Mar 2007
Longer than P75 for phase_2 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJuly 18, 2013
July 1, 2013
4.5 years
January 19, 2007
July 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of mother with plasma HIV1 below 200 copies per ml after 8 weeks of treatment
W8
Secondary Outcomes (6)
Proportion of women maintained with monotherapy until delivery,
delivery
Proportion of women with a VL below 50 copies per ml at delivery
delivery
Proportion of women harbouring resistant HIV strains four weeks after delivery
W4 post partum
Concentrations of studied drug in plasma and in cord-blood
at delivery
HIV-1 detection and concentrations of studied drug in vaginal secretion before and after treatment
W0, W8 of treatment
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALKaletra (lopinavir/ritonavir)
2
ACTIVE COMPARATORKaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)
Interventions
Kaletra (lopinavir/ritonavir): (200/50 mg x2)x 2/d= 2 pills twice daily Combivir (zidovudine/lamivudine): (300/150mg) x 2/d=1 pill twice daily
Eligibility Criteria
You may qualify if:
- Pregnancy known before 24 weeks of gestation
- Documented HIV-1 infection without indication for ARV therapy
- CD4 count above or equal to 350 per mm3
- VL under 30 000 copies per ml
- Naïve for PI (except treatment during previous pregnancy)
- Informed consent signed
You may not qualify if:
- HIV2 infection or HIV1 group O infection
- Any pathology related to pregnancy
- Contra-indication to study drugs
- Unstable hypertension or diabetes
- Known risk of premature delivery
- In case of previous treatment with a protease inhibitor : presence of resistance mutations on the HIV-1 protease gene by genotyping analysis (1 mutation among V32I et I47A, I50V V82A/F/S/T, I84V, L90 M or more than 3 mutations among L10 F/I/R/V, K20/M/R, L24I, L33F, M46I/L, F53L, I54M/L/T/V, L63P, A71L/V/T,)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Abbottcollaborator
Study Sites (1)
Hopital Pitie salpetriere
Paris, 75013, France
Related Publications (2)
Sibiude J, Le Chenadec J, Bonnet D, Tubiana R, Faye A, Dollfus C, Mandelbrot L, Delmas S, Lelong N, Khoshnood B, Warszawski J, Blanche S; French National Agency for Research on AIDS and Viral Hepatitis French Perinatal Cohort/Protease Inhibitor Monotherapy Evaluation Trial. In utero exposure to zidovudine and heart anomalies in the ANRS French perinatal cohort and the nested PRIMEVA randomized trial. Clin Infect Dis. 2015 Jul 15;61(2):270-80. doi: 10.1093/cid/civ260. Epub 2015 Apr 1.
PMID: 25838291DERIVEDTubiana R, Mandelbrot L, Le Chenadec J, Delmas S, Rouzioux C, Hirt D, Treluyer JM, Ekoukou D, Bui E, Chaix ML, Blanche S, Warszawski J; ANRS 135 PRIMEVA (Protease Inhibitor Monotherapy Evaluation) Study Group. Lopinavir/ritonavir monotherapy as a nucleoside analogue-sparing strategy to prevent HIV-1 mother-to-child transmission: the ANRS 135 PRIMEVA phase 2/3 randomized trial. Clin Infect Dis. 2013 Sep;57(6):891-902. doi: 10.1093/cid/cit390. Epub 2013 Jun 12.
PMID: 23766338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland Tubiana, MD
AP-HP Hopital Pitie salpetriere
- STUDY CHAIR
Josiane Warszawski, MD
INSERM - INED Unité U822 France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 22, 2007
Study Start
March 1, 2007
Primary Completion
September 1, 2011
Study Completion
November 1, 2012
Last Updated
July 18, 2013
Record last verified: 2013-07