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.
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).
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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Lipodystrophy Severity Grading Scale (LSGS) Scores
Measure Description

Perception of body fat was assessed by the Lipodystrophy Severity Grading Scale (LSGS), a standardized measurement of subjective lipoatrophy (fat loss) and lipoaccumulation (fat gain) perceived by the participant and by the physician. The degree of lipoatrophy and diffuse fat accumulation at each region was rated by both the participant and the physician as: Score 0=absent; Score 1=mild or noticeable on close inspection; Score 2=moderate or readily noticeable by patient/physician; Score 3=severe or readily noticeable to a casual observer.

Score A reflects the lipoatrophy or fat loss perception at the face, arms, buttocks and legs and ranges from 0-12.

Score B reflects the perception of fat gain at the abdomen, neck, and breasts and ranges from 0-9.

The overall score is the sum of the scores A+B, and ranges from 0-21.

Higher numbers indicate more fat loss (Score A) or gain (Score B). An average overall patient/physician score >7 indicates a clinical diagnosis of lipodystrophy.

Time Frame Study visit  
Safety Issue No  

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.
All participants for whom data were available. The number of participants included in the analysis of each score for each group of participants is shown as "N" (EFV and then LPV/r).

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).

Measured Values
    Efavirenz     Lopinavir / Ritonavir  
Number of Participants Analyzed  
[units: participants]
  237     109  
Lipodystrophy Severity Grading Scale (LSGS) Scores  
[units: units on a scale]
Mean ± Standard Deviation
   
Patient Score A (fat loss) [N=233, 105]     1.02  ± 1.92     1.12  ± 2.00  
Patient Score B (fat gain) [N=235, 103]     0.98  ± 1.50     1.17  ± 1.86  
Patient Overall Score [N=233, 102]     2.01  ± 2.68     2.33  ± 3.00  
Physician Score A (fat loss) [N=233, 105]     0.70  ± 1.27     1.04  ± 1.76  
Physician Score B (fat gain) [N=235, 103]     0.60  ± 1.10     0.76  ± 1.35  
Physician Overall Score [N=233, 102]     1.31  ± 1.80     1.83  ± 2.43  

No statistical analysis provided for Lipodystrophy Severity Grading Scale (LSGS) Scores



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


  Other Adverse Events


  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.


Limitations and Caveats
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.  


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


No publications provided


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