Atazanavir and Lamivudine for Treatment Simplification (AtLaS)
Objectives of the study:
- 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.
- 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.
Drug: Lamiduvine (Epivir)
Drug: Atazanavir (Reyataz)
Drug: Ritonavir (Norvir)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Atazanavir/Ritonavir + Lamivudine in Patients Stably Treated With Two NRTIs + Atazanavir/Ritonavir With Optimal Virologic Response.|
- Proportion 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 ] [ Designated as safety issue: No ]
- Time to Virological Failure at Survival Analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Proportion of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Evolution of CD4 Cell Count During the 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Evolution of Adherence and Quality of Life During the 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Evolution of Atazanavir Plasma Concentrations During the 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Change of Metabolic Parameters at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Change of the Results of Neurocognitive Tests at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Change of Bone Density and of Subcutaneous Fat at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Single arm
Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
Drug: Lamiduvine (Epivir)
Epivir 300 mgDrug: Atazanavir (Reyataz)
Reyataz 300 mgDrug: Ritonavir (Norvir)
Norvir 100 mg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885482
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|
|Principal Investigator:||Andrea De Luca, MD||Catholic University of Sacred Heart|