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

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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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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Measure Type	Primary
Measure Title	Total Limb Fat Mass
Measure Description	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.
Time Frame	Study visit
Safety Issue	No

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.
All participants for whom data were available.

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).

Measured Values

	Efavirenz	Lopinavir / Ritonavir
Number of Participants Analyzed [units: participants]	232	106
Total Limb Fat Mass [units: kg] Mean ± Standard Deviation	8.84 ± 4.45	9.13 ± 6.26

No statistical analysis provided for Total Limb Fat Mass

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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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01159743 History of Changes
Other Study ID Numbers:	P12-031
Study First Received:	July 8, 2010
Results First Received:	September 28, 2012
Last Updated:	January 16, 2013
Health Authority:	Spain: Spanish Agency of Medicines

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