Status:
COMPLETED
Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. ANRS 135 Primeva
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Abbott
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
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...
Detailed Description
Recent data from the French perinatal cohort and others indicate that HIV-RNA levels at delivery correlate with risk of transmission among women treated with antiretroviral agents. Most of these treat...
Eligibility Criteria
Inclusion
- Assessed between 20 and 24 months of pregnancy
- 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
Exclusion
- 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,)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00424814
Start Date
March 1 2007
End Date
November 1 2012
Last Update
July 18 2013
Active Locations (1)
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1
Hopital Pitie salpetriere
Paris, France, 75013