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)

This study has been completed.

Sponsor:

Collaborator:

Demométrica

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT01159743

First received: July 8, 2010

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Results First Received: September 28, 2012

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

Participant Flow

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Recruitment Details

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Pre-Assignment Details

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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

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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
Number of Participants [units: participants]	237	109	346
Age ^[1] [units: years] Mean ± Standard Deviation	42.2 ± 9.74	44.3 ± 9.46	42.8 ± 9.69
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) ^[2] [units: participants]	236	109	345
Cluster of differentiation 4 (CD4)+ T-cell count ^[3] [units: cells/µL] Mean ± Standard Deviation	585.56 ± 246.87	592.75 ± 258.77	587.82 ± 250.31
CD4+ T-cell count nadir ^[4] [units: cells/µL] Mean ± Standard Deviation	216.85 ± 121.88	169.94 ± 153.84	202.00 ± 134.39
Previous acquired immunodeficiency syndrome (AIDS) diagnosis ^[5] [units: participants]
Yes	39	34	73
No	198	74	272

[1]	Data available for 235 and 109 patients in each treatment group respectively, 344 total patients.
[2]	Data available for 236 and 109 patients in each treatment group respectively, 345 total patients.
[3]	Data available for 236 and 108 patients in each treatment group respectively, 344 total patients.
[4]	Data available for 231 and 107 patients in each treatment group respectively, 338 total patients.
[5]	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%)

Other Adverse Events

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Limitations and Caveats

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