Clinical trial NCT01159743: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: lipodystrophy
Lipoatrophy
antiretroviral treatment
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Demométrica
First posted: 2010-07-09
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients visiting Spanish HIV clinics.

Brief 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).

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 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.

Primary outcomes:
measure: Total Limb Fat Mass
timeFrame: Study visit
Secondary outcomes:
measure: Distribution of Body Fat Mass
timeFrame: Study visit
measure: Lipodystrophy Severity Grading Scale (LSGS) Scores
timeFrame: Study visit
measure: Change Over Time in Body Fat Distribution
timeFrame: 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).
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Site Reference ID/Investigator# 39595
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 39602
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 39605
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 39589
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 39601
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 39593
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 39603
city: Bilbao
country: Spain
facility: Site Reference ID/Investigator# 39587
city: Cabuenes-Gijon
country: Spain
facility: Site Reference ID/Investigator# 39596
city: Granada
country: Spain
facility: Site Reference ID/Investigator# 39590
city: La Laguna Teneriffe
country: Spain
facility: Site Reference ID/Investigator# 39604
city: Logrono
country: Spain
facility: Site Reference ID/Investigator# 39609
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 39597
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 39600
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 39591
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 24822
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 39586
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 39599
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 39611
city: Malaga
country: Spain
facility: Site Reference ID/Investigator# 39588
city: San Sebastian
country: Spain
facility: Site Reference ID/Investigator# 39592
city: Seville
country: Spain
facility: Site Reference ID/Investigator# 39606
city: Valencia
country: Spain
facility: Site Reference ID/Investigator# 39598
city: Valencia
country: Spain
facility: Site Reference ID/Investigator# 39612
city: Vigo
country: Spain
facility: Site Reference ID/Investigator# 39607
city: Zaragoza
country: Spain
facility: Site Reference ID/Investigator# 39610
Study officials:
affiliation: Abbvie Farmaceutica S.L.U. Spain
name: Angel Burgos, Other
role: STUDY_DIRECTOR
References: