Conditions: HIV Infections
Keywords: HIV/AIDS HAART Simplification Atazanavir Lamivudine treatment experienced
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 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.

Interventions: intervention 1: Lamiduvine (Epivir) intervention 2: Atazanavir (Reyataz) intervention 3: Ritonavir (Norvir)
Intervention descriptions: intervention 1: Epivir 300 mg intervention 2: Reyataz 300 mg intervention 3: Norvir 100 mg

Protocol document: