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A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving, Since the Beginning and for at Least Two Years, an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir Combined With Tenofovir + Emtricitabine or Lamivudine (LYNX)

This study has been completed.
Sponsor:
Collaborator:
Demométrica
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01159743
First received: July 8, 2010
Last updated: January 16, 2013
Last verified: January 2013
Results First Received: September 28, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: HIV Infection

  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
Efavirenz Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
Lopinavir / Ritonavir HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).

Participant Flow:   Overall Study
    Efavirenz   Lopinavir / Ritonavir
STARTED   237   109 
COMPLETED   237   109 
NOT COMPLETED   0   0 



  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
Efavirenz Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
Lopinavir / Ritonavir HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
Total Total of all reporting groups

Baseline Measures
   Efavirenz   Lopinavir / Ritonavir   Total 
Overall Participants Analyzed 
[Units: Participants]
 237   109   346 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 42.2  (9.74)   44.3  (9.46)   42.8  (9.69) 
[1] Data available for 235 and 109 patients in each treatment group respectively, 344 total patients.
Gender 
[Units: Participants]
     
Female   38   17   55 
Male   199   92   291 
Region of Enrollment 
[Units: Participants]
     
Spain   237   109   346 
Hepatitis C Virus (HCV) Co-infection 
[Units: Participants]
     
HCV positive   41   33   74 
HCV negative   196   76   272 
Time on current antiretroviral regimen 
[Units: Participants]
     
2 - 3 years   75   27   102 
3 - 4 years   76   32   108 
More than 4 years   86   50   136 
Undetectable HIV-1 RNA (< 50 copies/mL) [1] 
[Units: Participants]
 236   109   345 
[1] Data available for 236 and 109 patients in each treatment group respectively, 345 total patients.
Cluster of differentiation 4 (CD4)+ T-cell count [1] 
[Units: cells/µL]
Mean (Standard Deviation)
 585.56  (246.87)   592.75  (258.77)   587.82  (250.31) 
[1] Data available for 236 and 108 patients in each treatment group respectively, 344 total patients.
CD4+ T-cell count nadir [1] 
[Units: cells/µL]
Mean (Standard Deviation)
 216.85  (121.88)   169.94  (153.84)   202.00  (134.39) 
[1] Data available for 231 and 107 patients in each treatment group respectively, 338 total patients.
Previous acquired immunodeficiency syndrome (AIDS) diagnosis [1] 
[Units: Participants]
     
Yes   39   34   73 
No   198   74   272 
[1] Data available for 237 and 108 patients in each treatment group respectively, 345 total patients.


  Outcome Measures
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1.  Primary:   Total Limb Fat Mass   [ Time Frame: Study visit ]

2.  Secondary:   Distribution of Body Fat Mass   [ Time Frame: Study visit ]

3.  Secondary:   Lipodystrophy Severity Grading Scale (LSGS) Scores   [ Time Frame: Study visit ]

4.  Secondary:   Change Over Time in Body Fat Distribution   [ Time Frame: DEXA performed at the study visit and more than 6 months prior to the study visit (the period of time between the DEXA recorded at the study visit and the previous DEXA ranged from 6 to 36 months). ]


  Serious Adverse Events
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Additional Description No text entered.

Reporting Groups
  Description
Efavirenz Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
Lopinavir / Ritonavir HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).

Serious Adverse Events
    Efavirenz   Lopinavir / Ritonavir
Total, serious adverse events     
# participants affected / at risk   0/237 (0.00%)   0/109 (0.00%) 




  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01159743     History of Changes
Other Study ID Numbers: P12-031
Study First Received: July 8, 2010
Results First Received: September 28, 2012
Last Updated: January 16, 2013
Health Authority: Spain: Spanish Agency of Medicines