Status:
COMPLETED
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
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Demométrica
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
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 antiretrovir...
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, an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT01159743
Start Date
July 1 2010
End Date
September 1 2011
Last Update
January 24 2013
Active Locations (26)
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1
Site Reference ID/Investigator# 39595
Alicante, Spain, 03010
2
Site Reference ID/Investigator# 39602
Barcelona, Spain, 08003
3
Site Reference ID/Investigator# 39605
Barcelona, Spain, 08035
4
Site Reference ID/Investigator# 39589
Barcelona, Spain, 08036