ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01159743
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : October 30, 2012
Last Update Posted : January 24, 2013
Sponsor:
Collaborator:
Demométrica
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition HIV Infection
Enrollment 346
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Efavirenz Lopinavir / Ritonavir
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 237 109
Completed 237 109
Not Completed 0 0
Arm/Group Title Efavirenz Lopinavir / Ritonavir Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 237 109 346
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 237 participants 109 participants 346 participants
42.2  (9.74) 44.3  (9.46) 42.8  (9.69)
[1]
Measure Description: Data available for 235 and 109 patients in each treatment group respectively, 344 total patients.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 237 participants 109 participants 346 participants
Female
38
  16.0%
17
  15.6%
55
  15.9%
Male
199
  84.0%
92
  84.4%
291
  84.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 237 participants 109 participants 346 participants
237 109 346
Hepatitis C Virus (HCV) Co-infection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 237 participants 109 participants 346 participants
HCV positive 41 33 74
HCV negative 196 76 272
Time on current antiretroviral regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 237 participants 109 participants 346 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 237 participants 109 participants 346 participants
236 109 345
[1]
Measure Description: Data available for 236 and 109 patients in each treatment group respectively, 345 total patients.
Cluster of differentiation 4 (CD4)+ T-cell count   [1] 
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 237 participants 109 participants 346 participants
585.56  (246.87) 592.75  (258.77) 587.82  (250.31)
[1]
Measure Description: Data available for 236 and 108 patients in each treatment group respectively, 344 total patients.
CD4+ T-cell count nadir   [1] 
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 237 participants 109 participants 346 participants
216.85  (121.88) 169.94  (153.84) 202.00  (134.39)
[1]
Measure Description: Data available for 231 and 107 patients in each treatment group respectively, 338 total patients.
Previous acquired immunodeficiency syndrome (AIDS) diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 237 participants 109 participants 346 participants
Yes 39 34 73
No 198 74 272
[1]
Measure Description: Data available for 237 and 108 patients in each treatment group respectively, 345 total patients.
1.Primary Outcome
Title Total Limb Fat Mass
Hide Description Total limb fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan. DEXA uses a whole body scanner and two different low-dose x-rays to read bone mass and soft tissue mass.
Time Frame Study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants for whom data were available.
Arm/Group Title Efavirenz Lopinavir / Ritonavir
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 232 106
Mean (Standard Deviation)
Unit of Measure: kg
8.84  (4.45) 9.13  (6.26)
2.Secondary Outcome
Title Distribution of Body Fat Mass
Hide Description Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.
Time Frame Study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants for whom data were available. The number of participants included in the analysis of each category for each group of participants is shown as "N" (EFV and then LPV/r).
Arm/Group Title Efavirenz Lopinavir / Ritonavir
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 237 109
Mean (Standard Deviation)
Unit of Measure: kg
Total body fat mass [N=231, 106] 20.13  (7.56) 20.24  (8.60)
Trunk fat mass [N=232, 106] 10.77  (4.84) 10.76  (5.24)
Upper limb fat mass [N=232, 106] 2.11  (1.07) 2.08  (1.14)
Lower limb fat mass [N=232, 106] 6.72  (3.68) 7.04  (5.72)
3.Secondary Outcome
Title Lipodystrophy Severity Grading Scale (LSGS) Scores
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Efavirenz Lopinavir / Ritonavir
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 237 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
4.Secondary Outcome
Title Change Over Time in Body Fat Distribution
Hide Description

Change over time in total body fat and fat in the limbs and trunk was assessed by dual X-ray absorptiometry (DEXA) in participants for whom a DEXA measurement performed at least 6 months before participation in this study was available.

A negative change score indicates fat loss over time and a positive change score indicates fat gain over time.

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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants for whom a dual X-ray absorptiometry measurement performed at least 6 months before participation in this study was available.
Arm/Group Title Efavirenz Lopinavir / Ritonavir
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 34 14
Mean (Standard Deviation)
Unit of Measure: kg
Total fat mass -0.05  (4.02) -0.06  (7.34)
Trunk fat mass 0.32  (2.23) -0.05  (4.04)
Limb fat mass 0.16  (2.43) 0.10  (3.37)
Upper limb fat mass 0.39  (0.69) -0.03  (0.66)
Lower limb fat mass 0.12  (2.13) 0.13  (2.80)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Efavirenz Lopinavir / Ritonavir
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Efavirenz Lopinavir / Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Efavirenz Lopinavir / Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/237 (0.00%)   0/109 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Efavirenz Lopinavir / Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/237 (0.00%)   0/109 (0.00%) 
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
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
First Submitted: July 8, 2010
First Posted: July 9, 2010
Results First Submitted: September 28, 2012
Results First Posted: October 30, 2012
Last Update Posted: January 24, 2013