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Atazanavir and Lamivudine for Treatment Simplification (AtLaS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea De Luca, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00885482
First received: April 20, 2009
Last updated: February 23, 2015
Last verified: February 2015
Results First Received: February 4, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Lamiduvine (Epivir)
Drug: Atazanavir (Reyataz)
Drug: Ritonavir (Norvir)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Single Arm
STARTED   40 
COMPLETED   36 
NOT COMPLETED   4 
Pregnancy                1 
Lack of Efficacy                1 
Death                1 
low Therapeutic drug monitoring (TDM)                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Baseline Measures
   Single Arm 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   38 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (9) 
Gender 
[Units: Participants]
 
Female   17 
Male   23 
Region of Enrollment 
[Units: Participants]
 
Italy   40 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Time to Virological Failure at Survival Analysis   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Evolution of CD4 Cell Count During the 48 Weeks   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Evolution of Adherence and Quality of Life During the 48 Weeks   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Evolution of Atazanavir Plasma Concentrations During the 48 Weeks   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Change of Metabolic Parameters at 48 Weeks   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Change of the Results of Neurocognitive Tests at 48 Weeks   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Change of Bone Density and of Subcutaneous Fat at 48 Weeks   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrea De Luca
Organization: Catholic University of S. Heart
phone: +390630155366
e-mail: deluca.andrea@fastwebnet.it


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

Responsible Party: Andrea De Luca, 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