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Sponsor: ANRS, Emerging Infectious Diseases
Conditions: HIV Infections
Interventions: Kaletra (lopinavir/ritonavir), Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)
Countries: France
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.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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,)
- Paris, France