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)
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| ClinicalTrials.gov Identifier: NCT01159743 |
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Recruitment Status
:
Completed
First Posted
: July 9, 2010
Results First Posted
: October 30, 2012
Last Update Posted
: January 24, 2013
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| Condition or disease |
|---|
| HIV Infection |
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.
| Study Type : | Observational |
| Actual Enrollment : | 346 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| 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 Start Date : | July 2010 |
| Actual Primary Completion Date : | September 2011 |
| Actual Study Completion Date : | September 2011 |
| Group/Cohort |
|---|
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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).
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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).
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- Total Limb Fat Mass [ Time Frame: Study visit ]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.
- Distribution of Body Fat Mass [ Time Frame: Study visit ]Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.
- Lipodystrophy Severity Grading Scale (LSGS) Scores [ Time Frame: Study visit ]
Perception of body fat was assessed by the Lipodystrophy Severity Grading Scale (LSGS), a standardized measurement of subjective lipoatrophy (fat loss) and lipoaccumulation (fat gain) perceived by the participant and by the physician. The degree of lipoatrophy and diffuse fat accumulation at each region was rated by both the participant and the physician as: Score 0=absent; Score 1=mild or noticeable on close inspection; Score 2=moderate or readily noticeable by patient/physician; Score 3=severe or readily noticeable to a casual observer.
Score A reflects the lipoatrophy or fat loss perception at the face, arms, buttocks and legs and ranges from 0-12.
Score B reflects the perception of fat gain at the abdomen, neck, and breasts and ranges from 0-9.
The overall score is the sum of the scores A+B, and ranges from 0-21.
Higher numbers indicate more fat loss (Score A) or gain (Score B). An average overall patient/physician score >7 indicates a clinical diagnosis of lipodystrophy.
- Change Over Time in Body Fat Distribution [ Time Frame: 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). ]
Change over time in total body fat and fat in the limbs and trunk was assessed by dual X-ray absorptiometry (DEXA) in participants for whom a DEXA measurement performed at least 6 months before participation in this study was available.
A negative change score indicates fat loss over time and a positive change score indicates fat gain over time.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159743
| Spain | |
| Site Reference ID/Investigator# 39595 | |
| Alicante, Spain, 03010 | |
| Site Reference ID/Investigator# 39602 | |
| Barcelona, Spain, 08003 | |
| Site Reference ID/Investigator# 39605 | |
| Barcelona, Spain, 08035 | |
| Site Reference ID/Investigator# 39589 | |
| Barcelona, Spain, 08036 | |
| Site Reference ID/Investigator# 39601 | |
| Barcelona, Spain, 08041 | |
| Site Reference ID/Investigator# 39593 | |
| Barcelona, Spain, 08916 | |
| Site Reference ID/Investigator# 39603 | |
| Barcelona, Spain, 8907 | |
| Site Reference ID/Investigator# 39587 | |
| Bilbao, Spain, 48013 | |
| Site Reference ID/Investigator# 39596 | |
| Cabuenes-Gijon, Spain, 33394 | |
| Site Reference ID/Investigator# 39590 | |
| Granada, Spain, 18017 | |
| Site Reference ID/Investigator# 39604 | |
| La Laguna Teneriffe, Spain, 38320 | |
| Site Reference ID/Investigator# 39609 | |
| Logrono, Spain, 26006 | |
| Site Reference ID/Investigator# 39597 | |
| Madrid, Spain, 28007 | |
| Site Reference ID/Investigator# 39600 | |
| Madrid, Spain, 28034 | |
| Site Reference ID/Investigator# 39591 | |
| Madrid, Spain, 28040 | |
| Site Reference ID/Investigator# 24822 | |
| Madrid, Spain, 28041 | |
| Site Reference ID/Investigator# 39586 | |
| Madrid, Spain, 28041 | |
| Site Reference ID/Investigator# 39599 | |
| Madrid, Spain, 28046 | |
| Site Reference ID/Investigator# 39611 | |
| Madrid, Spain, 28880 | |
| Site Reference ID/Investigator# 39588 | |
| Malaga, Spain, 29010 | |
| Site Reference ID/Investigator# 39592 | |
| San Sebastian, Spain, 20014 | |
| Site Reference ID/Investigator# 39606 | |
| Seville, Spain, 41013 | |
| Site Reference ID/Investigator# 39598 | |
| Valencia, Spain, 46009 | |
| Site Reference ID/Investigator# 39612 | |
| Valencia, Spain, 46014 | |
| Site Reference ID/Investigator# 39607 | |
| Vigo, Spain, 36204 | |
| Site Reference ID/Investigator# 39610 | |
| Zaragoza, Spain, 50009 | |
| Study Director: | Angel Burgos, Other | Abbvie Farmaceutica S.L.U. Spain |
Additional Information:
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT01159743 History of Changes |
| Other Study ID Numbers: |
P12-031 |
| First Posted: | July 9, 2010 Key Record Dates |
| Results First Posted: | October 30, 2012 |
| Last Update Posted: | January 24, 2013 |
| Last Verified: | January 2013 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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lipodystrophy Lipoatrophy antiretroviral treatment |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir Lamivudine Emtricitabine Efavirenz |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers |