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)

AbbVie

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01159743

P12-031

Details and patient eligibility

About

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).

Full 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.

Enrollment: 346 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

346 participants in 2 patient groups

Efavirenz

Description:

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

Description:

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).