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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  
Number of Participants  
[units: participants]
  237     109     346  
Age [1]
[units: years]
Mean ± Standard Deviation
  42.2  ± 9.74     44.3  ± 9.46     42.8  ± 9.69  
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) [2]
[units: participants]
  236     109     345  
Cluster of differentiation 4 (CD4)+ T-cell count [3]
[units: cells/µL]
Mean ± Standard Deviation
  585.56  ± 246.87     592.75  ± 258.77     587.82  ± 250.31  
CD4+ T-cell count nadir [4]
[units: cells/µL]
Mean ± Standard Deviation
  216.85  ± 121.88     169.94  ± 153.84     202.00  ± 134.39  
Previous acquired immunodeficiency syndrome (AIDS) diagnosis [5]
[units: participants]
     
Yes     39     34     73  
No     198     74     272  
[1] Data available for 235 and 109 patients in each treatment group respectively, 344 total patients.
[2] Data available for 236 and 109 patients in each treatment group respectively, 345 total patients.
[3] Data available for 236 and 108 patients in each treatment group respectively, 344 total patients.
[4] Data available for 231 and 107 patients in each treatment group respectively, 338 total patients.
[5] 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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  Limitations and Caveats


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