Atazanavir and Lamivudine for Treatment Simplification - Full Text View

Purpose

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	Intervention	Phase
HIV Infections	Drug: Lamiduvine (Epivir) Drug: Atazanavir (Reyataz) Drug: Ritonavir (Norvir)	Phase 4


Study Type:	Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Ritonavir Atazanavir Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Virological Failure at Survival Analysis [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Number 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 ]


Enrollment:	40
Study Start Date:	May 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months
Aged 18 years or older
Who gave informed consent to the participation to the study
With at least two viral load < 50 copies/mL in two consecutive determinations at least 3 months apart
With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least

Exclusion Criteria:

Pregnancy or breast feeding, desire of pregnancy in the short term
Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues
Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline
Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)
Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885482

Locations


Italy
Catholic University of Sacred Heart
Rome, Italy, 00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators


Principal Investigator:	Andrea De Luca, MD	Catholic University of Sacred Heart

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fabbiani M, Bracciale L, Doino M, D'Avino A, Marzocchetti A, Navarra P, Cauda R, De Luca A, Di Giambenedetto S. Tenofovir discontinuation could predispose to urolithiasis in atazanavir-treated patients. J Infect. 2011 Apr;62(4):319-21. doi: 10.1016/j.jinf.2011.02.004. Epub 2011 Feb 15.


Responsible Party:	Andrea De Luca, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00885482 History of Changes
Other Study ID Numbers:	2009−011273−32
Study First Received:	April 20, 2009
Results First Received:	February 4, 2015
Last Updated:	February 23, 2015
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency

Keywords provided by Catholic University of the Sacred Heart:


HIV/AIDS HAART Simplification	Atazanavir Lamivudine treatment experienced

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate Lamivudine	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016

Atazanavir and Lamivudine for Treatment Simplification (AtLaS)