Atazanavir and Lamivudine for Treatment Simplification

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives of the study:

1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.

2. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.

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

Details

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

Criteria

Inclusion Criteria:

• Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months

• Aged 18 years or older

• Who gave informed consent to the participation to the study

• With at least two viral load < 50 copies/mL in two consecutive determinations at least 3 months apart

• With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least

Exclusion Criteria:

• Pregnancy or breast feeding, desire of pregnancy in the short term

• Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues

• Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline

• Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)

• Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications