Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy
KRETA
A Phase IV-III Comparative, Randomized, Open-label Study to Evaluate the Efficacy for the Recovery of Peripheral Fat (or of the Extremities) of Lopinavir/Ritonavir in Monotherapy Versus Abacavir/Lamivudine and Lopinavir/Ritonavir
2 other identifiers
interventional
88
1 country
11
Brief Summary
The aim of this study is to evaluate the efficacy for the recovery of peripheral fat of lopinavir/ritonavir in monotherapy versus abacavir/lamivudine and lopinavir/ritonavir in subjects who developed lipoatrophy while receiving zidovudine plus lamivudine plus abacavir.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2008
Longer than P75 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMarch 22, 2013
March 1, 2013
3.5 years
March 18, 2009
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in limb fat measured by DEXA at 48w
48 weeks
Secondary Outcomes (2)
Absolute change in limb-fat measured by DEXA at 96 weeks
96 weeks
Lipid changes at Week 24, 48, 72 and 96
96 weeks
Study Arms (2)
Monotherapy group
EXPERIMENTALLopinavir/ritonavir (LPV/r).
Triple arm
ACTIVE COMPARATORLopinavir/ritonavir (LPV/r)+ ABC/3TC
Interventions
Eligibility Criteria
You may qualify if:
- Confirmation of the willingness of the patient to participate in this study after being informed on all the aspects of the trial that may influence their decision, signing and dating the written informed consent form approved by the Ethics Committee.
- The patient is 18 years of age or older.
- (Documented) HIV-1 infection.
- Receiving treatment with ZDV+3TC+ABC (in continuous antiretroviral treatment, without discontinuation periods, for the past 6 months).
- A viral burden below 50 copies/mL no more than 30 days before starting the study.
- No previous history of virological failure while on antiretroviral treatment with protease inhibitors (PIs). That is, they have never switched protease inhibitors for suspected or documented virological failure. The changes in protease inhibitor due solely to toxicity, simplification or optimization are acceptable.
- Absence of signs of acute disease.
- Patient has not been treated for an active opportunistic infection within the 30 days prior to the baseline visit.
- Patient with Karnofsky index \>- 70.
- During the study, the patient does not require and agrees not to take any of the following drugs that are contraindicated with LPV/r: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, methylergonovine), pimozide, propafenone, and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication due to the possibility of a significant decrease in LPV/r concentrations during concomitant administration, nor drugs contraindicated with 3TC and ABC that in principle should not be being taken, as they are part of the treatment at the screening.
- Patient agrees not to take any medication, including over-the-counter medicines, alcohol, drugs, or herbal preparations without the knowledge and approval of the principal investigator.
- Laboratory tests have been performed on the patients in the past 30 days:
- G/dL hemoglobin \>8.0
- Absolute neutrophil count 750 cells/microl
- Platelet count 20,000/microl
- +4 more criteria
You may not qualify if:
- Patients with a history of virological failure on treatment with PIs; that is, that they have at some point switched to PIs for confirmed or documented virological failure.
- Patients with positive serum hepatitis B surface antigen.
- Patients requiring treatment with drugs where combination with LPV/r is contraindicated.
- Presence of active opportunistic disease or wasting syndrome or under antitumoral treatment with chemotherapy.
- Patients treated in the previous 16 weeks with agents susceptible to insulin (glitazones or metformin), anabolic steroids, growth hormone or any agent that could interfere with the study drugs.
- Active drug addiction or psychiatric disease that may prevent protocol compliance. Use of cannabis or being on methadone treatment are excepted, provided protocol compliance is not compromised in the investigator's opinion.
- Pregnant women or nursing mothers, and women of childbearing age if they do not agree to use a barrier contraceptive method throughout the study of proven reliability in the investigator's opinion.
- In the opinion of the principal investigator, the patient is unlikely to comply with the study protocol, or the patient is not eligible for any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion SEIMC-GESIDAlead
- Abbottcollaborator
Study Sites (11)
Hospital General Universitario de Alicante
Alicante, Alicante, 03010, Spain
Hospital Sant Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Clinico y Provincial
Barcelona, Barcelona, 08036, Spain
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital La Paz
Madrid, Madrid, 28006, Spain
Hospital Doce de Octubre
Madrid, Madrid, 28041, Spain
Hospital La Paz
Madrid, Madrid, 28046, Spain
Hospital Xeral Cies
Vigo, Pontevedra, 36204, Spain
Hospital de Donostia
Donostia / San Sebastian, San Sebastian, 20014, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Related Publications (1)
Bernardino JI, Pulido F, Martinez E, Arrizabalaga J, Domingo P, Portilla J, Ocampo A, Munoz J, Torres R, Arribas JR; GESIDA-6008-KRETA Study Group. Switching to lopinavir/ritonavir with or without abacavir/lamivudine in lipoatrophic patients treated with zidovudine/abacavir/lamivudine. J Antimicrob Chemother. 2013 Jun;68(6):1373-81. doi: 10.1093/jac/dks540. Epub 2013 Feb 5.
PMID: 23386261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jose Ignacio Bernardino
Hospital La Paz
- STUDY CHAIR
Jose Ramon Arribas
Hospital La Paz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2009
First Posted
March 19, 2009
Study Start
December 1, 2008
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
March 22, 2013
Record last verified: 2013-03