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.
Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density. Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Epivir 300 mg
Reyataz 300 mg
Norvir 100 mg
Catholic University of Sacred Heart
Rome, Italy
Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis
Time frame: 48 weeks
Time to Virological Failure at Survival Analysis
Time frame: 48 weeks
Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis
Time frame: 48 weeks
Evolution of CD4 Cell Count During the 48 Weeks
Time frame: 48 weeks
Evolution of Adherence and Quality of Life During the 48 Weeks
Time frame: 48 weeks
Evolution of Atazanavir Plasma Concentrations During the 48 Weeks
Time frame: 48 weeks
Change of Metabolic Parameters at 48 Weeks
Time frame: 48 weeks
Change of the Results of Neurocognitive Tests at 48 Weeks
Time frame: 48 weeks
Change of Bone Density and of Subcutaneous Fat at 48 Weeks
Time frame: 48 weeks
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