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

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

Male

199

291

Region of Enrollment
[Units: Participants]

Spain

237

109

346

Hepatitis C Virus (HCV) Co-infection
[Units: Participants]

HCV positive

HCV negative

196

272

Time on current antiretroviral regimen
[Units: Participants]

2 - 3 years

102

3 - 4 years

108

More than 4 years

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

198

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%)

Other Adverse Events

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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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