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)
|ClinicalTrials.gov Identifier: NCT01159743|
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : October 30, 2012
Last Update Posted : January 24, 2013
|Condition or disease|
Lipodystrophy (also called abnormal fat redistribution) associated with HIV infection is characterized by loss of subcutaneous adipose tissue (lipoatrophy) that is more apparent in the limbs, face, and buttocks, or by accumulation of adipose tissue (lipohypertrophy) in the intra-abdominal cavity, the mid, upper back, and breasts. Lipodystrophy may also occur in a mixed form (lipoatrophy and lipohypertrophy in the same patient).
Participants made a single study visit. Dual energy X-ray absorptiometry (DEXA) was performed within 30 days of this study visit. In addition, routine visit clinical results, demographic data, disease data, comorbidities and concomitant medications were collected.
|Study Type :||Observational|
|Actual Enrollment :||346 participants|
|Official Title:||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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
HIV-infected patients on initial 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 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 Limb Fat Mass [ Time Frame: Study visit ]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.
- Distribution of Body Fat Mass [ Time Frame: Study visit ]Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.
- Lipodystrophy Severity Grading Scale (LSGS) Scores [ Time Frame: Study visit ]
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.
- 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). ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159743
|Site Reference ID/Investigator# 39595|
|Alicante, Spain, 03010|
|Site Reference ID/Investigator# 39602|
|Barcelona, Spain, 08003|
|Site Reference ID/Investigator# 39605|
|Barcelona, Spain, 08035|
|Site Reference ID/Investigator# 39589|
|Barcelona, Spain, 08036|
|Site Reference ID/Investigator# 39601|
|Barcelona, Spain, 08041|
|Site Reference ID/Investigator# 39593|
|Barcelona, Spain, 08916|
|Site Reference ID/Investigator# 39603|
|Barcelona, Spain, 8907|
|Site Reference ID/Investigator# 39587|
|Bilbao, Spain, 48013|
|Site Reference ID/Investigator# 39596|
|Cabuenes-Gijon, Spain, 33394|
|Site Reference ID/Investigator# 39590|
|Granada, Spain, 18017|
|Site Reference ID/Investigator# 39604|
|La Laguna Teneriffe, Spain, 38320|
|Site Reference ID/Investigator# 39609|
|Logrono, Spain, 26006|
|Site Reference ID/Investigator# 39597|
|Madrid, Spain, 28007|
|Site Reference ID/Investigator# 39600|
|Madrid, Spain, 28034|
|Site Reference ID/Investigator# 39591|
|Madrid, Spain, 28040|
|Site Reference ID/Investigator# 24822|
|Madrid, Spain, 28041|
|Site Reference ID/Investigator# 39586|
|Madrid, Spain, 28041|
|Site Reference ID/Investigator# 39599|
|Madrid, Spain, 28046|
|Site Reference ID/Investigator# 39611|
|Madrid, Spain, 28880|
|Site Reference ID/Investigator# 39588|
|Malaga, Spain, 29010|
|Site Reference ID/Investigator# 39592|
|San Sebastian, Spain, 20014|
|Site Reference ID/Investigator# 39606|
|Seville, Spain, 41013|
|Site Reference ID/Investigator# 39598|
|Valencia, Spain, 46009|
|Site Reference ID/Investigator# 39612|
|Valencia, Spain, 46014|
|Site Reference ID/Investigator# 39607|
|Vigo, Spain, 36204|
|Site Reference ID/Investigator# 39610|
|Zaragoza, Spain, 50009|
|Study Director:||Angel Burgos, Other||Abbvie Farmaceutica S.L.U. Spain|