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

NCT ID: NCT01159743

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 346 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-09-30

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.

Conditions

HIV Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

No interventions assigned to this group

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).

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Demométrica

UNKNOWN

Sponsor Role: collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angel Burgos, Other

Role: STUDY_DIRECTOR

Abbvie Farmaceutica S.L.U. Spain

Locations

Site Reference ID/Investigator# 39595

Alicante, , Spain

Site Reference ID/Investigator# 39602

Barcelona, , Spain

Site Reference ID/Investigator# 39605

Barcelona, , Spain

Site Reference ID/Investigator# 39589

Barcelona, , Spain

Site Reference ID/Investigator# 39601

Barcelona, , Spain

Site Reference ID/Investigator# 39593

Barcelona, , Spain

Site Reference ID/Investigator# 39603

Barcelona, , Spain

Site Reference ID/Investigator# 39587

Bilbao, , Spain

Site Reference ID/Investigator# 39596

Cabuenes-Gijon, , Spain

Site Reference ID/Investigator# 39592

Donostia / San Sebastian, , Spain

Site Reference ID/Investigator# 39590

Granada, , Spain

Site Reference ID/Investigator# 39604

La Laguna Teneriffe, , Spain

Site Reference ID/Investigator# 39609

Logroño, , Spain

Site Reference ID/Investigator# 39597

Madrid, , Spain

Site Reference ID/Investigator# 39600

Madrid, , Spain

Site Reference ID/Investigator# 39591

Madrid, , Spain

Site Reference ID/Investigator# 24822

Madrid, , Spain

Site Reference ID/Investigator# 39586

Madrid, , Spain

Site Reference ID/Investigator# 39599

Madrid, , Spain

Site Reference ID/Investigator# 39611

Madrid, , Spain

Site Reference ID/Investigator# 39588

Málaga, , 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, , Spain

Countries

Spain

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P12-031

Identifier Type: -

Identifier Source: org_study_id