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

July 8, 2010
January 16, 2013
July 2010
September 2011   (final data collection date for primary outcome measure)
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.
Limb fat mass (in kg) assessed by dual energy X-ray absorptiometry (DEXA scan). [ Time Frame: +/- 15 days around study baseline visit ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01159743 on ClinicalTrials.gov Archive Site
  • 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.

Perception of body fat assessed by Lipodystrophy Severity Grading Scale [ Time Frame: study baseline visit ] [ Designated as safety issue: No ]
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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
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

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

HIV-infected patients visiting Spanish HIV clinics.

HIV Infection
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  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
346
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01159743
P12-031
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Demométrica
Study Director: Angel Burgos, Other Abbvie Farmaceutica S.L.U. Spain
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP