Atazanavir/r + Lamivudine Dual Therapy

• Status: Completed
• Trial end date: 2018-02-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Atazanavir Sulfate; Lamivudine; Ritonavir

Criteria

Inclusion Criteria

• HIV positive patients 18 years of age or older who signed an informed consent form

• Already on cART, without any treatment interruption.

• 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).

• Patients with non-AIDS related illnesses which could, in the Clinician's judgement, jeopardize the patient's compliance to the study procedures (i.e. Child-Pugh B or higher liver cirrhosis, active cancers on treatment…).

• Patients treated with proton-pump inhibitors or other concomitant medication with potential for interactions reducing exposure to atazanavir