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Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy (KRETA)
This study is currently recruiting participants.
Verified by Fundacion SEIMC-GESIDA, March 2009
First Received: March 18, 2009   Last Updated: April 7, 2009   History of Changes
Sponsor: Fundacion SEIMC-GESIDA
Information provided by: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT00865007
  Purpose

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.


Condition Intervention Phase
HIV Infection
Lipodystrophy
HIV Infections
Drug: Monotherapy (Lopinavir/ritonavir)
Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC
Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • Absolute change in limb fat measured by DEXA at 48w [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absolute change in limb-fat measured by DEXA at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Lipid changes at Week 24, 48, 72 and 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Monotherapy group: Experimental
Lopinavir/ritonavir (LPV/r).
Drug: Monotherapy (Lopinavir/ritonavir)
NRTI sparing
Triple arm: Active Comparator
Lopinavir/ritonavir (LPV/r)+ ABC/3TC
Drug: Monotherapy (Lopinavir/ritonavir)
NRTI sparing
Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC
NRTI sparing regimen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • There is confirmation that during the 6 months prior to inclusion in the study the viral burdens were below 50 copies/mL.
  • 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.
  • Clinical evidence of moderate to severe lipoatrophy (according to the case definition as scoring >- 2. For inclusion in the study, the subject should have moderate to severe lipoatrophy in at least one site, and defined by the physician.
  • 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
  • ALT or AST <5 x upper normal limit (UNL)
  • Creatinine <1. 5 x UNL
  • Triglycerides <750 mg/dL.
  • For women, a negative result of a pregnancy test is available and they agree to use throughout the study a barrier contraceptive method of proven reliability in the investigator's opinion.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865007

Contacts
Contact: Elena Barquilla 0034 91 556 80 25 ebarquilla@f-sg.org
Contact: Herminia Esteban 0034 91 556 80 25 hesteban@f-sg.org

Locations
Spain
Hospital General Universitario de Alicante Recruiting
Alicante, Spain, 03010
Contact: Joaquin Portilla     0034 965 93 89 79        
Principal Investigator: Joaquin Portilla, Dr.            
Hospital Clinico y Provincial Recruiting
Barcelona, Spain, 08036
Contact: Esteban Martinez, Dr.     0034 932 27 54 00        
Principal Investigator: Esteban Martinez, Dr.            
Hospital Sant Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Pere Domingo, Dr.     0034 932 91 90 00        
Principal Investigator: Pere Domingo, Dr.            
Hospital Universitario Reina Sofia Recruiting
Cordoba, Spain, 14004
Contact: Antonio Rivero, Dr.     0034 957 01 16 13        
Principal Investigator: Antonio Rivero, Dr.            
Hospital La Paz Recruiting
Madrid, Spain, 28046
Contact: Jose Ignacio Bernardino, Dr.     0034 91 358 20 66        
Principal Investigator: Jose Ignacio Bernardino, Dr.            
Hospital La Paz Recruiting
Madrid, Spain, 28006
Contact: José Ramon Arribas, Dr.     0034 91 358 20 66        
Contact: , Dr.            
Principal Investigator: Jose Ramon Arribas, Dr            
Hospital Doce de Octubre Recruiting
Madrid, Spain, 28041
Contact: Federico Pulido, Dr.     34 91 390 82 02        
Principal Investigator: Federico Pulido, Dr.            
Spain, Madrid
Hospital Severo Ochoa Recruiting
Leganes, Madrid, Spain, 28911
Contact: Rafael Torres, Dr.     0034 91481 80 00        
Principal Investigator: Rafael Torres, Dr.            
Spain, Pontevedra
Hospital Xeral Cies Recruiting
Vigo, Pontevedra, Spain, 36204
Contact: Antonio Ocampo, Dr.     0034 986 81 60 00        
Principal Investigator: Antonio Ocampo, Dr.            
Spain, San Sebastian
Hospital de Donostia Recruiting
Donostia, San Sebastian, Spain, 20014
Contact: Julio Arrizabalaga, Dr.     0034 943 44 70 00        
Principal Investigator: Julio Arrizabalaga, Dr.            
Spain, Vizcaya
Hospital de Basurto Recruiting
Bilbao, Vizcaya, Spain, 48013
Contact: Josefa Muñoz, Dra.     0034 944 00 60 75        
Principal Investigator: Josefa Muñoz, Dra.            
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Investigators
Study Chair: Jose Ignacio Bernardino Hospital La Paz
Study Chair: Jose Ramon Arribas Hospital La Paz
  More Information

No publications provided

Responsible Party: SEIMC-GESIDA Foundation ( Jose Ignacio Bernardino )
Study ID Numbers: GESIDA-6008
Study First Received: March 18, 2009
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00865007     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion SEIMC-GESIDA:
Lipodystrophy
treatment experienced

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Lopinavir
Therapeutic Uses
Lipodystrophy
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Metabolic Diseases
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
HIV Infections
Skin Diseases, Metabolic
Ritonavir

ClinicalTrials.gov processed this record on February 08, 2010