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. (AtLaS)

NCT00885482 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Catholic University of the Sacred Heart
Phase	Phase 4
Status	COMPLETED
Enrolment	40
Start date	2009-05
Completion	2011-05

Conditions

• HIV Infections

Interventions

• Lamiduvine (Epivir)
• Atazanavir (Reyataz)
• Ritonavir (Norvir)

Primary outcomes

• 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 — 48 weeks

Countries

Italy