We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Lamiduvine (Epivir) Drug: Atazanavir (Reyataz) Drug: Ritonavir (Norvir) Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2009
Primary Completion Date : May 2010
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time to Virological Failure at Survival Analysis [ Time Frame: 48 weeks ]
  2. Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis [ Time Frame: 48 weeks ]
  3. Evolution of CD4 Cell Count During the 48 Weeks [ Time Frame: 48 weeks ]
  4. Evolution of Adherence and Quality of Life During the 48 Weeks [ Time Frame: 48 weeks ]
  5. Evolution of Atazanavir Plasma Concentrations During the 48 Weeks [ Time Frame: 48 weeks ]
  6. Change of Metabolic Parameters at 48 Weeks [ Time Frame: 48 weeks ]
  7. Change of the Results of Neurocognitive Tests at 48 Weeks [ Time Frame: 48 weeks ]
  8. Change of Bone Density and of Subcutaneous Fat at 48 Weeks [ Time Frame: 48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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):
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
First Posted: April 22, 2009    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: March 13, 2015
Last Verified: February 2015

Keywords provided by Andrea De Luca, 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