Trial Outcomes & Findings for 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 (NCT NCT01159743)

Last Updated: 2013-01-24

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

346 participants

Primary outcome timeframe

Study visit

Results posted on

2013-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	237	109
Overall Study COMPLETED	237	109
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Efavirenz n=237 Participants 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).	Lopinavir / Ritonavir n=109 Participants 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).	Total n=346 Participants Total of all reporting groups
Age Continuous	42.2 years STANDARD_DEVIATION 9.74 • n=99 Participants	44.3 years STANDARD_DEVIATION 9.46 • n=107 Participants	42.8 years STANDARD_DEVIATION 9.69 • n=206 Participants
Sex: Female, Male Female	38 Participants n=99 Participants	17 Participants n=107 Participants	55 Participants n=206 Participants
Sex: Female, Male Male	199 Participants n=99 Participants	92 Participants n=107 Participants	291 Participants n=206 Participants
Region of Enrollment Spain	237 participants n=99 Participants	109 participants n=107 Participants	346 participants n=206 Participants
Hepatitis C Virus (HCV) Co-infection HCV positive	41 participants n=99 Participants	33 participants n=107 Participants	74 participants n=206 Participants
Hepatitis C Virus (HCV) Co-infection HCV negative	196 participants n=99 Participants	76 participants n=107 Participants	272 participants n=206 Participants
Time on current antiretroviral regimen 2 - 3 years	75 participants n=99 Participants	27 participants n=107 Participants	102 participants n=206 Participants
Time on current antiretroviral regimen 3 - 4 years	76 participants n=99 Participants	32 participants n=107 Participants	108 participants n=206 Participants
Time on current antiretroviral regimen More than 4 years	86 participants n=99 Participants	50 participants n=107 Participants	136 participants n=206 Participants
Undetectable HIV-1 RNA (< 50 copies/mL)	236 participants n=99 Participants	109 participants n=107 Participants	345 participants n=206 Participants
Cluster of differentiation 4 (CD4)+ T-cell count	585.56 cells/µL STANDARD_DEVIATION 246.87 • n=99 Participants	592.75 cells/µL STANDARD_DEVIATION 258.77 • n=107 Participants	587.82 cells/µL STANDARD_DEVIATION 250.31 • n=206 Participants
CD4+ T-cell count nadir	216.85 cells/µL STANDARD_DEVIATION 121.88 • n=99 Participants	169.94 cells/µL STANDARD_DEVIATION 153.84 • n=107 Participants	202.00 cells/µL STANDARD_DEVIATION 134.39 • n=206 Participants
Previous acquired immunodeficiency syndrome (AIDS) diagnosis Yes	39 participants n=99 Participants	34 participants n=107 Participants	73 participants n=206 Participants
Previous acquired immunodeficiency syndrome (AIDS) diagnosis No	198 participants n=99 Participants	74 participants n=107 Participants	272 participants n=206 Participants

PRIMARY outcome

Timeframe: Study visit

Population: All participants for whom data were available.

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.

Outcome measures

Outcome measures
Measure	Efavirenz n=232 Participants 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).	Lopinavir / Ritonavir n=106 Participants 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).
Total Limb Fat Mass	8.84 kg Standard Deviation 4.45	9.13 kg Standard Deviation 6.26

SECONDARY outcome

Timeframe: Study visit

Population: 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).

Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.

Outcome measures

Outcome measures
Measure	Efavirenz n=237 Participants 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).	Lopinavir / Ritonavir n=109 Participants 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).
Distribution of Body Fat Mass Upper limb fat mass [N=232, 106]	2.11 kg Standard Deviation 1.07	2.08 kg Standard Deviation 1.14
Distribution of Body Fat Mass Total body fat mass [N=231, 106]	20.13 kg Standard Deviation 7.56	20.24 kg Standard Deviation 8.60
Distribution of Body Fat Mass Trunk fat mass [N=232, 106]	10.77 kg Standard Deviation 4.84	10.76 kg Standard Deviation 5.24
Distribution of Body Fat Mass Lower limb fat mass [N=232, 106]	6.72 kg Standard Deviation 3.68	7.04 kg Standard Deviation 5.72

SECONDARY outcome

Timeframe: Study visit

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Efavirenz n=237 Participants 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).	Lopinavir / Ritonavir n=109 Participants 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).
Lipodystrophy Severity Grading Scale (LSGS) Scores Patient Score A (fat loss) [N=233, 105]	1.02 units on a scale Standard Deviation 1.92	1.12 units on a scale Standard Deviation 2.00
Lipodystrophy Severity Grading Scale (LSGS) Scores Patient Score B (fat gain) [N=235, 103]	0.98 units on a scale Standard Deviation 1.50	1.17 units on a scale Standard Deviation 1.86
Lipodystrophy Severity Grading Scale (LSGS) Scores Physician Score B (fat gain) [N=235, 103]	0.60 units on a scale Standard Deviation 1.10	0.76 units on a scale Standard Deviation 1.35
Lipodystrophy Severity Grading Scale (LSGS) Scores Patient Overall Score [N=233, 102]	2.01 units on a scale Standard Deviation 2.68	2.33 units on a scale Standard Deviation 3.00
Lipodystrophy Severity Grading Scale (LSGS) Scores Physician Score A (fat loss) [N=233, 105]	0.70 units on a scale Standard Deviation 1.27	1.04 units on a scale Standard Deviation 1.76
Lipodystrophy Severity Grading Scale (LSGS) Scores Physician Overall Score [N=233, 102]	1.31 units on a scale Standard Deviation 1.80	1.83 units on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: 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).

Population: Participants for whom a dual X-ray absorptiometry measurement performed at least 6 months before participation in this study was available.

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.

Outcome measures

Outcome measures
Measure	Efavirenz n=34 Participants 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).	Lopinavir / Ritonavir n=14 Participants 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).
Change Over Time in Body Fat Distribution Total fat mass	-0.05 kg Standard Deviation 4.02	-0.06 kg Standard Deviation 7.34
Change Over Time in Body Fat Distribution Trunk fat mass	0.32 kg Standard Deviation 2.23	-0.05 kg Standard Deviation 4.04
Change Over Time in Body Fat Distribution Limb fat mass	0.16 kg Standard Deviation 2.43	0.10 kg Standard Deviation 3.37
Change Over Time in Body Fat Distribution Upper limb fat mass	0.39 kg Standard Deviation 0.69	-0.03 kg Standard Deviation 0.66
Change Over Time in Body Fat Distribution Lower limb fat mass	0.12 kg Standard Deviation 2.13	0.13 kg Standard Deviation 2.80

Adverse Events

Efavirenz

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lopinavir / Ritonavir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER