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 purpose of this study is to compare the body fat distribution in Human Immunodeficiency Virus-1 (HIV-1) infected patients receiving, since the beginning and for at least two years, an antiretroviral therapy based on efavirenz or lopinavir/ritonavir and a combination of tenofovir plus emtricitabine (or lamivudine).
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|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|
- Total Limb Fat Mass [ Time Frame: Study visit ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.
- Lipodystrophy Severity Grading Scale (LSGS) Scores [ Time Frame: Study visit ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
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.
|Study Start Date:||July 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159743
|Site Reference ID/Investigator# 39595|
|Alicante, Spain, 03010|
|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# 39602|
|Barcelona, Spain, 08003|
|Site Reference ID/Investigator# 39603|
|Barcelona, Spain, 8907|
|Site Reference ID/Investigator# 39593|
|Barcelona, Spain, 08916|
|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# 24822|
|Madrid, Spain, 28041|
|Site Reference ID/Investigator# 39586|
|Madrid, Spain, 28041|
|Site Reference ID/Investigator# 39591|
|Madrid, Spain, 28040|
|Site Reference ID/Investigator# 39597|
|Madrid, Spain, 28007|
|Site Reference ID/Investigator# 39599|
|Madrid, Spain, 28046|
|Site Reference ID/Investigator# 39600|
|Madrid, Spain, 28034|
|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|