NCT00885482

Atazanavir and Lamivudine for Treatment Simplification

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Lamiduvine (Epivir)	Epivir 300 mg
DRUG	Atazanavir (Reyataz)	Reyataz 300 mg
DRUG	Ritonavir (Norvir)	Norvir 100 mg

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2011-05-01
• First posted: 2009-04-22
• Last updated: 2015-03-13
• Results posted: 2015-02-23

Locations

1 site across 1 country: Italy