Atazanavir and Lamivudine for Treatment Simplification (AtLaS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00885482|
Recruitment Status : Completed
First Posted : April 22, 2009
Results First Posted : February 23, 2015
Last Update Posted : March 13, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Lamiduvine (Epivir) Drug: Atazanavir (Reyataz) Drug: Ritonavir (Norvir)||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2011|
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 mg
Drug: Atazanavir (Reyataz)
Reyataz 300 mg
Drug: Ritonavir (Norvir)
Norvir 100 mg
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885482
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|
|Principal Investigator:||Andrea De Luca, MD||Catholic University of Sacred Heart|