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)

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Cross-Sectional
Condition:	HIV Infection

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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).

Participant Flow:   Overall Study

	Efavirenz	Lopinavir / Ritonavir
STARTED	237	109
COMPLETED	237	109
NOT COMPLETED	0	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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).
Total	Total of all reporting groups

Baseline Measures

	Efavirenz	Lopinavir / Ritonavir	Total
Overall Participants Analyzed; [Units: Participants]	237	109	346
Age [1]; [Units: Years]; Mean (Standard Deviation)	42.2 (9.74)	44.3 (9.46)	42.8 (9.69)
[1] Data available for 235 and 109 patients in each treatment group respectively, 344 total patients.
Gender; [Units: Participants]
Female	38	17	55
Male	199	92	291
Region of Enrollment; [Units: Participants]
Spain	237	109	346
Hepatitis C Virus (HCV) Co-infection; [Units: Participants]
HCV positive	41	33	74
HCV negative	196	76	272
Time on current antiretroviral regimen; [Units: Participants]
2 - 3 years	75	27	102
3 - 4 years	76	32	108
More than 4 years	86	50	136
Undetectable HIV-1 RNA (< 50 copies/mL) [1]; [Units: Participants]	236	109	345
[1] Data available for 236 and 109 patients in each treatment group respectively, 345 total patients.
Cluster of differentiation 4 (CD4)+ T-cell count [1]; [Units: cells/µL]; Mean (Standard Deviation)	585.56 (246.87)	592.75 (258.77)	587.82 (250.31)
[1] Data available for 236 and 108 patients in each treatment group respectively, 344 total patients.
CD4+ T-cell count nadir [1]; [Units: cells/µL]; Mean (Standard Deviation)	216.85 (121.88)	169.94 (153.84)	202.00 (134.39)
[1] Data available for 231 and 107 patients in each treatment group respectively, 338 total patients.
Previous acquired immunodeficiency syndrome (AIDS) diagnosis [1]; [Units: Participants]
Yes	39	34	73
No	198	74	272
[1] Data available for 237 and 108 patients in each treatment group respectively, 345 total patients.

  Outcome Measures

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1. Primary:

Total Limb Fat Mass [ Time Frame: Study visit ]

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2. Secondary:

Distribution of Body Fat Mass [ Time Frame: Study visit ]

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3. Secondary:

Lipodystrophy Severity Grading Scale (LSGS) Scores [ Time Frame: Study visit ]

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4. Secondary:

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). ]

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  Serious Adverse Events

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Reporting Groups

	Description
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).

Serious Adverse Events

	Efavirenz	Lopinavir / Ritonavir
Total, Serious Adverse Events
# participants affected / at risk	0/237 (0.00%)	0/109 (0.00%)

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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