The purpose of this study is to evaluate the virological efficacy of maintenance therapy with atazanavir with ritonavir combined with lamivudine in treatment experienced HIV positive patients with full and stable virological suppression.
Name: Atazanavir, ritonavir, lamivudineDescription: Lamivudine 300 mg 1 pill once-a-day, atazanavir 300 mg 1 pill with ritonavir 100 mg 1 pill once-a-day, taken together orally with a light mealType: Drug
Description: Proportion of patients with viral load < 50 copies/mL at week 48 at the intention-to-treat with switch = failure analysisMeasure: Proportion of patients with viral load < 50 copies/mL Time: at week 48
There is one SNP
- Treated with a cART regimen containing atazanavir boosted with ritonavir since at least 3 months - With full virological suppression (VL<50 copies/mL) for a minimum of six months and in at least in two consecutive determination 3 months +/-2 weeks apart from each other - With CD4 cell count >200 since at least 6 months and without opportunistic infections or other AIDS-related events since at least one year before screening Exclusion Criteria: - Previous virological failure on a lamivudine- or PI-containing regimen or previous exposure to lamivudine-containing suboptimal antiretroviral regimens - Patients with at least a single viral load blip over 200 copies/mL - Patients with M184V or major atazanavir resistance mutation at previous genotypic resistance test (historical genotype) - Pregnancy or lactation, planned pregnancy in the short-term - Patients with HBsAg positive chronic HBV infection - Patients who experienced major toxicities related to any of the study drugs in the past - Patients with grade 4 laboratory abnormalities at baseline (excluding lipid profile and plasma bilirubin concentration). --- M184V ---
Lamivudine is a well tolerated NRTI which showed no significant toxicity in the short and long term and, together with its analog emtricitabine, is now a preferred option in most of the major international treatment guidelines; it has a good CNS penetration score and its only signature resistance mutation (M184V) deeply impairs the viral fitness and does not compromise the future treatment options. --- M184V ---