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 Overview

• Status: Completed
• Conditions: HIV Infection

Detailed Description

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
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Site Reference ID/Investigator# 39595
  • Barcelona, Spain, 08003
    • Site Reference ID/Investigator# 39602
  • Barcelona, Spain, 08035
    • Site Reference ID/Investigator# 39605
  • Barcelona, Spain, 08036
    • Site Reference ID/Investigator# 39589
  • Barcelona, Spain, 08041
    • Site Reference ID/Investigator# 39601
  • Barcelona, Spain, 08916
    • Site Reference ID/Investigator# 39593
  • Barcelona, Spain, 8907
    • Site Reference ID/Investigator# 39603
  • Bilbao, Spain, 48013
    • Site Reference ID/Investigator# 39587
  • Cabuenes-Gijon, Spain, 33394
    • Site Reference ID/Investigator# 39596
  • Granada, Spain, 18017
    • Site Reference ID/Investigator# 39590
  • La Laguna Teneriffe, Spain, 38320
    • Site Reference ID/Investigator# 39604
  • Logrono, Spain, 26006
    • Site Reference ID/Investigator# 39609
  • Madrid, Spain, 28007
    • Site Reference ID/Investigator# 39597
  • Madrid, Spain, 28034
    • Site Reference ID/Investigator# 39600
  • Madrid, Spain, 28040
    • Site Reference ID/Investigator# 39591
  • Madrid, Spain, 28041
    • Site Reference ID/Investigator# 24822
  • Madrid, Spain, 28041
    • Site Reference ID/Investigator# 39586
  • Madrid, Spain, 28046
    • Site Reference ID/Investigator# 39599
  • Madrid, Spain, 28880
    • Site Reference ID/Investigator# 39611
  • Malaga, Spain, 29010
    • Site Reference ID/Investigator# 39588
  • San Sebastian, Spain, 20014
    • Site Reference ID/Investigator# 39592
  • Seville, Spain, 41013
    • Site Reference ID/Investigator# 39606
  • Valencia, Spain, 46009
    • Site Reference ID/Investigator# 39598
  • Valencia, Spain, 46014
    • Site Reference ID/Investigator# 39612
  • Vigo, Spain, 36204
    • Site Reference ID/Investigator# 39607
  • Zaragoza, Spain, 50009
    • Site Reference ID/Investigator# 39610

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients visiting Spanish HIV clinics.

Description

Inclusion Criteria

• Men and women aged ≥ 18 years with HIV-1 infection who are clinically stable and who were invited to participate in the study at a routine follow-up visit.
• HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial antiretroviral therapy (ART) based on efavirenz (EFV) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)] or HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial ART based on lopinavir/ritonavir (LPV/r) and a combination of TDF +FTC (or 3TC).
• Patients with an undetectable viral load, in response to the detection limit of each participating hospital defined in the last 6 months.
• Patients who have given written informed consent to participate in this study [personal data collection and performance of dual energy X-ray absorptiometry (DEXA)].

Exclusion Criteria

• Patients who have received at some point both efavirenz (EFV) and lopinavir/ritonavir (LPV/r) in combination regimen or thereafter.
• Patients who have had structured treatment interruptions (therapeutic holidays).
• Patients with a body mass index <16 kg/m^2.
• Patients with metallic prostheses or prosthetic material that could interfere with the measurement of dual energy X-ray absorptiometry (DEXA).
• Patients with a history of plastic or repair surgery in the buttocks and breasts.
• Patients with a diagnostic test with barium or radionucleotides, performed during the last month.
• Pregnant women.
• Patients treated with other agents under investigational phase.
• Patients on current treatment with systemic corticosteroids or chemotherapy.
• Diabetes mellitus and hypoglycaemic treatment.
• Transsexualism (though implicit in prostheses and drugs).
• Any drug taken chronically, which may alter the distribution of fat or adipocyte biology (insulin, non-steroidal anti-inflammatory drugs, etc).
• Patient has undergone liposuction.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Efavirenz; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Limb Fat Mass	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.	Study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Body Fat Mass	Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.	Study visit
Lipodystrophy Severity Grading Scale (LSGS) Scores	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.	Study visit
Change Over Time in Body Fat Distribution	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.	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).

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Demométrica
• Investigators: Study Director: Angel Burgos, Other, Abbvie Farmaceutica S.L.U. Spain

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (ESTIMATE): July 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: antiretroviral treatment; lipodystrophy; Lipoatrophy
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: P12-031