Atazanavir and Lamivudine for Treatment Simplification (AtLaS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Catholic University of the Sacred Heart.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00885482
First received: April 20, 2009
Last updated: May 14, 2009
Last verified: April 2009
  Purpose

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.

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:


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

Primary Outcome Measures:
  • proportion 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 ]
  • Proportion 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 ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
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

Contacts
Contact: Andrea De Luca, MD 00390630154945 andrea.deluca@rm.unicatt.it

Locations
Italy
Catholic University of Sacred Heart Not yet recruiting
Rome, Italy, 00168
Contact: Andrea De Luca, MD    00390630154945    andrea.deluca@rm.unicatt.it   
Sub-Investigator: Manuela Colafigli, MD         
Sub-Investigator: Laura Bracciale, MD         
Sub-Investigator: Massimiliano Fabbiani, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Andrea De Luca, MD Catholic University of Sacred Heart
  More Information

No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Andrea De Luca, Catholic University of Sacred Heart
ClinicalTrials.gov Identifier: NCT00885482     History of Changes
Other Study ID Numbers: 2009−011273−32
Study First Received: April 20, 2009
Last Updated: May 14, 2009
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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Atazanavir
Lamivudine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014