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

HIV Infection Clinical Trial

— LYNX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159743
• Other study ID #: P12-031
• Status: Completed
• Phase: N/A
• First received: July 8, 2010
• Last updated: January 16, 2013
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Infection

Locations

Country	Name	City	State
Spain	Site Reference ID/Investigator# 39595	Alicante
Spain	Site Reference ID/Investigator# 39589	Barcelona
Spain	Site Reference ID/Investigator# 39593	Barcelona
Spain	Site Reference ID/Investigator# 39601	Barcelona
Spain	Site Reference ID/Investigator# 39602	Barcelona
Spain	Site Reference ID/Investigator# 39603	Barcelona
Spain	Site Reference ID/Investigator# 39605	Barcelona
Spain	Site Reference ID/Investigator# 39587	Bilbao
Spain	Site Reference ID/Investigator# 39596	Cabuenes-Gijon
Spain	Site Reference ID/Investigator# 39590	Granada
Spain	Site Reference ID/Investigator# 39604	La Laguna Teneriffe
Spain	Site Reference ID/Investigator# 39609	Logrono
Spain	Site Reference ID/Investigator# 24822	Madrid
Spain	Site Reference ID/Investigator# 39586	Madrid
Spain	Site Reference ID/Investigator# 39591	Madrid
Spain	Site Reference ID/Investigator# 39597	Madrid
Spain	Site Reference ID/Investigator# 39599	Madrid
Spain	Site Reference ID/Investigator# 39600	Madrid
Spain	Site Reference ID/Investigator# 39611	Madrid
Spain	Site Reference ID/Investigator# 39588	Malaga
Spain	Site Reference ID/Investigator# 39592	San Sebastian
Spain	Site Reference ID/Investigator# 39606	Seville
Spain	Site Reference ID/Investigator# 39598	Valencia
Spain	Site Reference ID/Investigator# 39612	Valencia
Spain	Site Reference ID/Investigator# 39607	Vigo
Spain	Site Reference ID/Investigator# 39610	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Demométrica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Distribution of Body Fat Mass	Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.	Study visit	No
Secondary	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	No
Secondary	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).	No

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