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| Name | Class |
|---|---|
| Demométrica | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Body Fat Mass | Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan. | Study visit |
| Lipodystrophy Severity Grading Scale (LSGS) Scores | 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. |
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Inclusion Criteria
Exclusion Criteria
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HIV-infected patients visiting Spanish HIV clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Angel Burgos, Other | Abbvie Farmaceutica S.L.U. Spain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 39595 | Alicante | 03010 | Spain | |||
| Site Reference ID/Investigator# 39602 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Efavirenz | Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC). |
| FG001 | Lopinavir / Ritonavir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Study visit |
| Change Over Time in Body Fat Distribution | 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. | 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). |
| Barcelona |
| 08003 |
| Spain |
| Site Reference ID/Investigator# 39605 | Barcelona | 08035 | Spain |
| Site Reference ID/Investigator# 39589 | Barcelona | 08036 | Spain |
| Site Reference ID/Investigator# 39601 | Barcelona | 08041 | Spain |
| Site Reference ID/Investigator# 39593 | Barcelona | 08916 | Spain |
| Site Reference ID/Investigator# 39603 | Barcelona | 8907 | Spain |
| Site Reference ID/Investigator# 39587 | Bilbao | 48013 | Spain |
| Site Reference ID/Investigator# 39596 | Cabuenes-Gijon | 33394 | Spain |
| Site Reference ID/Investigator# 39592 | Donostia / San Sebastian | 20014 | Spain |
| Site Reference ID/Investigator# 39590 | Granada | 18017 | Spain |
| Site Reference ID/Investigator# 39604 | La Laguna Teneriffe | 38320 | Spain |
| Site Reference ID/Investigator# 39609 | Logroño | 26006 | Spain |
| Site Reference ID/Investigator# 39597 | Madrid | 28007 | Spain |
| Site Reference ID/Investigator# 39600 | Madrid | 28034 | Spain |
| Site Reference ID/Investigator# 39591 | Madrid | 28040 | Spain |
| Site Reference ID/Investigator# 24822 | Madrid | 28041 | Spain |
| Site Reference ID/Investigator# 39586 | Madrid | 28041 | Spain |
| Site Reference ID/Investigator# 39599 | Madrid | 28046 | Spain |
| Site Reference ID/Investigator# 39611 | Madrid | 28880 | Spain |
| Site Reference ID/Investigator# 39588 | Málaga | 29010 | Spain |
| Site Reference ID/Investigator# 39606 | Seville | 41013 | Spain |
| Site Reference ID/Investigator# 39598 | Valencia | 46009 | Spain |
| Site Reference ID/Investigator# 39612 | Valencia | 46014 | Spain |
| Site Reference ID/Investigator# 39607 | Vigo | 36204 | Spain |
| Site Reference ID/Investigator# 39610 | Zaragoza | 50009 | Spain |
HIV-infected patients on initial and continuous 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). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Efavirenz | Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC). |
| BG001 | Lopinavir / Ritonavir | HIV-infected patients on initial and continuous 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Data available for 235 and 109 patients in each treatment group respectively, 344 total patients. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hepatitis C Virus (HCV) Co-infection | Number | participants |
| ||||||||||||||||
| Time on current antiretroviral regimen | Number | participants |
| ||||||||||||||||
| Undetectable HIV-1 RNA (< 50 copies/mL) | Data available for 236 and 109 patients in each treatment group respectively, 345 total patients. | Number | participants |
| |||||||||||||||
| Cluster of differentiation 4 (CD4)+ T-cell count | Data available for 236 and 108 patients in each treatment group respectively, 344 total patients. | Mean | Standard Deviation | cells/µL |
| ||||||||||||||
| CD4+ T-cell count nadir | Data available for 231 and 107 patients in each treatment group respectively, 338 total patients. | Mean | Standard Deviation | cells/µL |
| ||||||||||||||
| Previous acquired immunodeficiency syndrome (AIDS) diagnosis | Data available for 237 and 108 patients in each treatment group respectively, 345 total patients. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants for whom data were available. | Posted | Mean | Standard Deviation | kg | Study visit |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Distribution of Body Fat Mass | Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan. | All participants for whom data were available. The number of participants included in the analysis of each category for each group of participants is shown as "N" (EFV and then LPV/r). | Posted | Mean | Standard Deviation | kg | Study visit |
|
| |||||||||||||||||||||||||||||
| Secondary | Lipodystrophy Severity Grading Scale (LSGS) Scores | 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. | All participants for whom data were available. The number of participants included in the analysis of each score for each group of participants is shown as "N" (EFV and then LPV/r). | Posted | Mean | Standard Deviation | units on a scale | Study visit |
| ||||||||||||||||||||||||||||||
| Secondary | Change Over Time in Body Fat Distribution | 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. | Participants for whom a dual X-ray absorptiometry measurement performed at least 6 months before participation in this study was available. | Posted | Mean | Standard Deviation | kg | 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). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Efavirenz | Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC). | 0 | 237 | 0 | 237 | ||
| EG001 | Lopinavir / Ritonavir | HIV-infected patients on initial and continuous 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). | 0 | 109 | 0 | 109 |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
|
| HCV negative |
|
| 3 - 4 years |
|
| More than 4 years |
|
| No |
|
|
| Lopinavir / Ritonavir |
HIV-infected patients on initial and continuous 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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| Units | Counts |
|---|---|
| Participants |
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