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
  Purpose

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).


Condition
HIV Infection

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 346
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected patients visiting Spanish HIV clinics.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159743

Locations
Spain
Site Reference ID/Investigator# 39595
Alicante, Spain, 03010
Site Reference ID/Investigator# 39593
Barcelona, Spain, 08916
Site Reference ID/Investigator# 39589
Barcelona, Spain, 08036
Site Reference ID/Investigator# 39603
Barcelona, Spain, 8907
Site Reference ID/Investigator# 39602
Barcelona, Spain, 08003
Site Reference ID/Investigator# 39605
Barcelona, Spain, 08035
Site Reference ID/Investigator# 39601
Barcelona, Spain, 08041
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# 39586
Madrid, Spain, 28041
Site Reference ID/Investigator# 39591
Madrid, Spain, 28040
Site Reference ID/Investigator# 39600
Madrid, Spain, 28034
Site Reference ID/Investigator# 39597
Madrid, Spain, 28007
Site Reference ID/Investigator# 24822
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
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Demométrica
Investigators
Study Director: Angel Burgos, Other Abbvie Farmaceutica S.L.U. Spain
  More Information

Additional Information:
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

Keywords provided by AbbVie:
lipodystrophy
Lipoatrophy
antiretroviral treatment

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Lamivudine
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014