Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 4, 2015
Last verified: February 2015
Results First Received: February 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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  
confirmed low 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.
No text entered.

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  
Number of Participants  
[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:   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 ]

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

3.  Secondary:   Proportion 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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   Yes

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.   Safety Issue:   No

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

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.   Safety Issue:   Yes

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.   Safety Issue:   Yes


  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
No text entered.


  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


No publications provided by Catholic University of the Sacred Heart

Publications automatically indexed to this study:

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 4, 2015
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency