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

An observational study of HIV Infection, run by AbbVie (prior sponsor, Abbott) at 26 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare the body fat distribution in Human Immunodeficiency Virus-1 (HIV-1) infected patients receiving, since the beginning and for at least two years, an antiretroviral therapy based on efavirenz or lopinavir/ritonavir and a combination of tenofovir plus emtricitabine (or lamivudine). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
How many people: 346 participants
Where: 26 sitesSpain
Study dates: Jul 2010to Sep 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: HIV-infected patients visiting Spanish HIV clinics.

Who may be able to join

Men and women aged ≥ 18 years with HIV-1 infection who are clinically stable and who were invited to participate in the study at a routine follow-up visit.
HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial antiretroviral therapy (ART) based on efavirenz (EFV) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)] or HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial ART based on lopinavir/ritonavir (LPV/r) and a combination of TDF +FTC (or 3TC).
Patients with an undetectable viral load, in response to the detection limit of each participating hospital defined in the last 6 months.
Patients who have given written informed consent to participate in this study [personal data collection and performance of dual energy X-ray absorptiometry (DEXA)].

Who cannot join

Patients who have received at some point both efavirenz (EFV) and lopinavir/ritonavir (LPV/r) in combination regimen or thereafter.
Patients who have had structured treatment interruptions (therapeutic holidays).
Patients with a body mass index <16 kg/m^2.
Patients with metallic prostheses or prosthetic material that could interfere with the measurement of dual energy X-ray absorptiometry (DEXA).
Patients with a history of plastic or repair surgery in the buttocks and breasts.
Patients with a diagnostic test with barium or radionucleotides, performed during the last month.

Show all 13Show fewer

Pregnant women.
Patients treated with other agents under investigational phase.
Patients on current treatment with systemic corticosteroids or chemotherapy.
Diabetes mellitus and hypoglycaemic treatment.
Transsexualism (though implicit in prostheses and drugs).
Any drug taken chronically, which may alter the distribution of fat or adipocyte biology (insulin, non-steroidal anti-inflammatory drugs, etc).
Patient has undergone liposuction.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Spain26 sites

Site Reference ID/Investigator# 39595
Alicante, 03010
Site Reference ID/Investigator# 39602
Barcelona, 08003
Site Reference ID/Investigator# 39605
Barcelona, 08035
Site Reference ID/Investigator# 39589
Barcelona, 08036
Site Reference ID/Investigator# 39601
Barcelona, 08041
Site Reference ID/Investigator# 39593
Barcelona, 08916
Site Reference ID/Investigator# 39603
Barcelona, 8907
Site Reference ID/Investigator# 39587
Bilbao, 48013
Site Reference ID/Investigator# 39596
Cabuenes-Gijon, 33394
Site Reference ID/Investigator# 39592
Donostia / San Sebastian, 20014
Site Reference ID/Investigator# 39590
Granada, 18017
Site Reference ID/Investigator# 39604
La Laguna Teneriffe, 38320
Site Reference ID/Investigator# 39609
Logroño, 26006
Site Reference ID/Investigator# 39597
Madrid, 28007
Site Reference ID/Investigator# 39600
Madrid, 28034
Site Reference ID/Investigator# 39591
Madrid, 28040
Site Reference ID/Investigator# 24822
Madrid, 28041
Site Reference ID/Investigator# 39586
Madrid, 28041
Site Reference ID/Investigator# 39599
Madrid, 28046
Site Reference ID/Investigator# 39611
Madrid, 28880
Site Reference ID/Investigator# 39588
Málaga, 29010
Site Reference ID/Investigator# 39606
Seville, 41013
Site Reference ID/Investigator# 39598
Valencia, 46009
Site Reference ID/Investigator# 39612
Valencia, 46014
Site Reference ID/Investigator# 39607
Vigo, 36204
Site Reference ID/Investigator# 39610
Zaragoza, 50009

Other trials in Spain

About this study

Read the detailed description

Lipodystrophy (also called abnormal fat redistribution) associated with HIV infection is characterized by loss of subcutaneous adipose tissue (lipoatrophy) that is more apparent in the limbs, face, and buttocks, or by accumulation of adipose tissue (lipohypertrophy) in the intra-abdominal cavity, the mid, upper back, and breasts. Lipodystrophy may also occur in a mixed form (lipoatrophy and lipohypertrophy in the same patient).

Participants made a single study visit. Dual energy X-ray absorptiometry (DEXA) was performed within 30 days of this study visit. In addition, routine visit clinical results, demographic data, disease data, comorbidities and concomitant medications were collected.

Conditions: HIV Infection
Keywords: lipodystrophy, Lipoatrophy, antiretroviral treatment
Medical subject headings: HIV Infections, Lipodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01159743
Study group	Role	What they receive
Efavirenz		HIV-infected patients on initial 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 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Limb Fat Mass
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.
Measured: Study visit

Secondary outcomes (3)

Distribution of Body Fat Mass
Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.
Measured: Study visit
Lipodystrophy Severity Grading Scale (LSGS) Scores
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.
Measured: Study visit
Change Over Time in Body Fat Distribution
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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Sep 2011

First posted9 Jul 2010 (estimated)
Study startJul 2010
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 346 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01159743
Sponsor's protocol ID: P12-031
Acronym: LYNX
Status last verified: Jan 2013
First submitted: 8 Jul 2010
Last updated: 24 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01159743
Acronym / sponsor ID: LYNX / P12-031
Conditions: HIV Infection
Keywords: lipodystrophy, Lipoatrophy, antiretroviral treatment
Study type: Observational
Recruitment status: Completed
Enrolment: 346 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Demométrica
Study start: Jul 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 9 Jul 2010 (estimated)
Results: Posted 30 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Efavirenz	–	–HIV-infected patients on initial 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 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HIV-infected patients visiting Spanish HIV clinics.

Key inclusion criteria (4 listed)

Men and women aged ≥ 18 years with HIV-1 infection who are clinically stable and who were invited to participate in the study at a routine follow-up visit.
HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial antiretroviral therapy (ART) based on efavirenz (EFV) and a combination of tenofovir (TDF) + emtricitabine (FTC) [or lamivudine (3TC)] or HIV-1 infected patients receiving since the beginning and continuously, for at least two years, initial ART based on lopinavir/ritonavir (LPV/r) and a combination of TDF +FTC (or 3TC).
Patients with an undetectable viral load, in response to the detection limit of each participating hospital defined in the last 6 months.
Patients who have given written informed consent to participate in this study [personal data collection and performance of dual energy X-ray absorptiometry (DEXA)].

Key exclusion criteria (13 listed)

Patients who have received at some point both efavirenz (EFV) and lopinavir/ritonavir (LPV/r) in combination regimen or thereafter.
Patients who have had structured treatment interruptions (therapeutic holidays).
Patients with a body mass index <16 kg/m^2.
Patients with metallic prostheses or prosthetic material that could interfere with the measurement of dual energy X-ray absorptiometry (DEXA).
Patients with a history of plastic or repair surgery in the buttocks and breasts.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Total Limb Fat Mass
Time frame: Study visit
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.

3 secondary outcomes

Distribution of Body Fat Mass
Time frame: Study visit
Lipodystrophy Severity Grading Scale (LSGS) Scores
Time frame: Study visit
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).

Results and safety

Results posted to the registry on 30 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Efavirenz	237	237
Lopinavir / Ritonavir	109	109

Primary outcome: Total Limb Fat Mass

Time frame: Study visit. Mean (Standard Deviation). Unit: kg

Measure	Efavirenz n = 232	Lopinavir / Ritonavir n = 106
Value	8.84 (4.45)	9.13 (6.26)

Population analysed: All participants for whom data were available.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Efavirenz	0 of 237 (0%)	0 of 237 (0%)	Not reported
Lopinavir / Ritonavir	0 of 109 (0%)	0 of 109 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Angel Burgos, Other study director

Abbvie Farmaceutica S.L.U. Spain

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection, run by AbbVie (prior sponsor, Abbott) at 26 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Limb Fat Mass (time frame: Study visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01159743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.