Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator:
Abbott
Treatments:
Lamivudine
Lamivudine, zidovudine drug combination
Lopinavir
Reverse Transcriptase Inhibitors
Ritonavir
Zidovudine
Criteria
Inclusion Criteria: 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 Criteria:

- 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,)