HIV InfectionsPhase 4LIPOKALNCT00978237

Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients

A Phase 4 study testing EFV and LPV/r in people with HIV Infections and Lipoatrophy, run by Juan A. Arnaiz at 7 sites in Spain.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Lipoatrophy
What is being tested?: EFV and LPV/r
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 7 sitesSpain
Study dates: Oct 2009to Nov 2013
Phase: Phase 4
Are there results?: None posted in the registry

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

Who may be able to join

Patients HIV positive > 18 years.
Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
HIV-ARN < 50 copies/mL in the las six months.
Clinically evident lipoatrophy (moderate or severe).
Negative pregnancy test.
Signed informed consent.

Who cannot join

Evidence of failure or mutation to therapy with protease inhibitors.
Patients that can not be treated with LPV/r.
Mild lipoatrophy.
History of alcoholism or drug addiction that discourages participation in the study.
Pregnancy or breastfeeding.
Documented current or 4 weeks prior opportunistic infection.

Show all 12Show fewer

Creatinin clearance < 60mL/min.
Concomitant use of nephrotoxic drugs or immunosuppressants.
Actual treatment with systemic corticosteroids, IL-2 or chemotherapy.
Patients under treatment with other drugs in investigation.
Acute hepatitis.
Any other disease that discourages participation.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Spain7 sites

Hospital Universitario Central de Asturias
Asturias
Hospital Clínic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau de Barcelona
Barcelona
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Hospital Clínico San Carlos
Madrid
Hospital La Fe
Valencia
Hospital Xeral-Cíes
Vigo

Other trials in Spain

About this study

Official title: CT to Assess the Effect on the Subcutaneous Fat of Change of EFV for LPV/r in HIV-infected Patients Who Developed Lipoatrophy and Remains Despite Treatment With Efavirenz and Fixed-dose Combination of no Thymidine Nucleoside Analogues.

Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of correspondent analogues. The main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.

Conditions: HIV Infections, Lipoatrophy
Being tested: EFV, LPV/r
Keywords: HIV - Lipoatrophy, treatment experienced
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.

EFVDrug
one pill QD VO.
LPV/rDrug
2 pills QD VO

Study groups in NCT00978237
Study group	Role	What they receive
EFV and Fixed combinations of analogues	Active comparator	EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine Receives: Drug: EFV
LPV/r and combination of analogues.	Experimental	Not described Receives: Drug: LPV/r

What is being measured

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

Absolute change in limb fat mass measured by DEXA.
Measured: 24 months.

Timeline

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

Oct 2009Nov 2013

First posted16 Sep 2009 (estimated)
Study startOct 2009
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00978237
Sponsor's protocol ID: LIPOKAL
Acronym: LIPOKAL
Status last verified: Sep 2014
First submitted: 15 Sep 2009
Last updated: 18 Sep 2014
Results posted: No
Data monitoring committee: No

Publications

Rojas J, Lonca M, Imaz A, Estrada V, Asensi V, Miralles C, Domingo P, Montero M, del Rio L, Fontdevila J, Perez I, Cruceta A, Gatell JM, Arnedo M, Martinez E. Improvement of lipoatrophy by switching from efavirenz to lopinavir/ritonavir. HIV Med. 2016 May;17(5):340-9. doi: 10.1111/hiv.12314. Epub 2015 Sep 10.
PubMed 27089862

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CT to Assess the Effect on the Subcutaneous Fat of Change of EFV for LPV/r in HIV-infected Patients Who Developed Lipoatrophy and Remains Despite Treatment With Efavirenz and Fixed-dose Combination of no Thymidine Nucleoside Analogues.
ClinicalTrials.gov ID: NCT00978237
Acronym / sponsor ID: LIPOKAL / LIPOKAL
Conditions: HIV Infections, Lipoatrophy
Keywords: HIV - Lipoatrophy, treatment experienced
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Juan A. ArnaizUniversity, hospital or other
Study start: Oct 2009
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 16 Sep 2009 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
EFV and Fixed combinations of analogues	Active comparator	Drug: EFVEFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
LPV/r and combination of analogues.	Experimental	Drug: LPV/r

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients HIV positive > 18 years.
Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
HIV-ARN < 50 copies/mL in the las six months.
Clinically evident lipoatrophy (moderate or severe).
Negative pregnancy test.

Key exclusion criteria (12 listed)

Evidence of failure or mutation to therapy with protease inhibitors.
Patients that can not be treated with LPV/r.
Mild lipoatrophy.
History of alcoholism or drug addiction that discourages participation in the study.
Pregnancy or breastfeeding.

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

Interventions

Intervention	Type	Arms
EFVone pill QD VO.	Drug	EFV and Fixed combinations of analogues
LPV/r2 pills QD VO	Drug	LPV/r and combination of analogues.

Primary outcome

Absolute change in limb fat mass measured by DEXA.
Time frame: 24 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
Derived from this study: PubMed 27089862Rojas J, Lonca M, Imaz A, Estrada V, Asensi V, Miralles C, Domingo P, Montero M, del Rio L, Fontdevila J, Perez I, Cruceta A, Gatell JM, Arnedo M, Martinez E. Improvement of lipoatrophy by switching from efavirenz to lopinavir/ritonavir. HIV Med. 2016 May;17(5):340-9. doi: 10.1111/hiv.12314. Epub 2015 Sep 10.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EFV and LPV/r in people with HIV Infections and Lipoatrophy, run by Juan A. Arnaiz at 7 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 6 inclusion and 12 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Absolute change in limb fat mass measured by DEXA. (time frame: 24 months.). 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 NCT00978237, which also lists 1 linked publication.

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 18 Sep 2014.