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

NCT01159743 | Completed Results

• 1 other identifier: P12-031
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 26

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).

Conditions

HIV Infection

Keywords

lipodystrophy; Lipoatrophy; antiretroviral treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Distribution of Body Fat Mass

  Study visit

• Lipodystrophy Severity Grading Scale (LSGS) Scores

  Study visit

• Change Over Time in Body Fat Distribution

  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).

Study Arms (2)

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).

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients visiting Spanish HIV clinics.

You may qualify if:

• 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 \[personal data collection and performance of dual energy X-ray absorptiometry (DEXA)\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Demométrica: collaborator

Study Sites (26)

Site Reference ID/Investigator# 39595

Alicante, 03010, Spain

Location

Site Reference ID/Investigator# 39602

Barcelona, 08003, Spain

Location

Site Reference ID/Investigator# 39605

Barcelona, 08035, Spain

Location

Site Reference ID/Investigator# 39589

Barcelona, 08036, Spain

Location

Site Reference ID/Investigator# 39601

Barcelona, 08041, Spain

Location

Site Reference ID/Investigator# 39593

Barcelona, 08916, Spain

Location

Site Reference ID/Investigator# 39603

Barcelona, 8907, Spain

Location

Site Reference ID/Investigator# 39587

Bilbao, 48013, Spain

Location

Site Reference ID/Investigator# 39596

Cabuenes-Gijon, 33394, Spain

Location

Site Reference ID/Investigator# 39592

Donostia / San Sebastian, 20014, Spain

Location

Site Reference ID/Investigator# 39590

Granada, 18017, Spain

Location

Site Reference ID/Investigator# 39604

La Laguna Teneriffe, 38320, Spain

Location

Site Reference ID/Investigator# 39609

Logroño, 26006, Spain

Location

Site Reference ID/Investigator# 39597

Madrid, 28007, Spain

Location

Site Reference ID/Investigator# 39600

Madrid, 28034, Spain

Location

Site Reference ID/Investigator# 39591

Madrid, 28040, Spain

Location

Site Reference ID/Investigator# 24822

Madrid, 28041, Spain

Location

Site Reference ID/Investigator# 39586

Madrid, 28041, Spain

Location

Site Reference ID/Investigator# 39599

Madrid, 28046, Spain

Location

Site Reference ID/Investigator# 39611

Madrid, 28880, Spain

Location

Site Reference ID/Investigator# 39588

Málaga, 29010, Spain

Location

Site Reference ID/Investigator# 39606

Seville, 41013, Spain

Location

Site Reference ID/Investigator# 39598

Valencia, 46009, Spain

Location

Site Reference ID/Investigator# 39612

Valencia, 46014, Spain

Location

Site Reference ID/Investigator# 39607

Vigo, 36204, Spain

Location

Site Reference ID/Investigator# 39610

Zaragoza, 50009, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections; Lipodystrophy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Angel Burgos, Other

  Abbvie Farmaceutica S.L.U. Spain

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 24, 2013
• Results First Posted: October 30, 2012

Record last verified: 2013-01

Locations

ES (26)