Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy (KRETA)

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT00865007
First received: March 18, 2009
Last updated: March 21, 2013
Last verified: March 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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 ]

Enrollment: 88
Study Start Date: December 2008
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy group
Lopinavir/ritonavir (LPV/r).
Drug: Monotherapy (Lopinavir/ritonavir)
NRTI sparing
Active Comparator: Triple arm
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865007

Locations
Spain
Hospital Severo Ochoa
Leganes, Madrid, Spain, 28911
Hospital Xeral Cies
Vigo, Pontevedra, Spain, 36204
Hospital de Donostia
Donostia, San Sebastian, Spain, 20014
Hospital de Basurto
Bilbao, Vizcaya, Spain, 48013
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Sant Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinico y Provincial
Barcelona, Spain, 08036
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital La Paz
Madrid, Spain, 28046
Hospital La Paz
Madrid, Spain, 28006
Hospital Doce de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Abbott
Investigators
Study Chair: Jose Ignacio Bernardino Hospital La Paz
Study Chair: Jose Ramon Arribas Hospital La Paz
  More Information

No publications provided by Fundacion SEIMC-GESIDA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT00865007     History of Changes
Other Study ID Numbers: GESIDA-6008, 2008-003748-12
Study First Received: March 18, 2009
Last Updated: March 21, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion SEIMC-GESIDA:
Lipodystrophy
treatment experienced

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

ClinicalTrials.gov processed this record on October 20, 2014