Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir (BIOKAL)

This study has been terminated.

(patient sample not reached)

Sponsor:

Information provided by (Responsible Party):

Ines Perez, Hospital San Carlos, Madrid

ClinicalTrials.gov Identifier:

NCT01031849

First received: December 4, 2009

Last updated: April 5, 2013

Last verified: April 2013

History of Changes

Purpose

The objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)

Condition	Intervention	Phase
HIV Infections	Drug: Kaletra	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label)
Official Title:	Análisis de Los Cambios en el Tejido Adiposo de Pacientes Con infección VIH y Lipoatrofia en Tratamiento Con análogos de nucleósidos timidínicos, Tras el Cambio a Monoterapia Con Lopinavir/Ritonavir

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Ines Perez, Hospital San Carlos, Madrid:

Primary Outcome Measures:

Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted) [ Time Frame: 48 and 96 weeks ]

Secondary Outcome Measures:

Changes in physical fat deposits [ Time Frame: Baseline, 24, 48, 72 and 96 weeks ]
Changes in leptine and adiponectine plasma levels [ Time Frame: baseline, 24, 48, 72 and 96 weeks ]
Patients percentage with virologic response (ARN-VIH< 50 copies/mL) [ Time Frame: 48 and 96 weeks ]


Enrollment:	7
Study Start Date:	February 2010
Study Completion Date:	November 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Kaletra, all patients Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day	Drug: Kaletra Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients infected with VIH-1, documented with a positive HIV-1 antibody test and/or positive PCR, confirmed for HIV-1 RNA.
Patients treated with a HAART that should contain AZT+3TC+ABC (Trizivir®)
Patients with an indetectable viral load, which will be defined <40 copies/mL within the last six months.
Patients with a lipoatrophy clinical evidence (which will be defined as moderate or severe, according to the Lipodystrophy Severity Grading Scale).
Men or women aged ≥ 18.
For women of childbearing potential, negative urine pregnancy test during the Screening visit.
Patients that have signed and dated the Informed consent Form prior to any Study-specific procedure.

Exclusion Criteria:

Patients with evidence of protease inhibitors failure, and/or documented evidence of protease gene resistance mutation. This evidence could be prior or during the inclusion period in the Study.
Patients who, for any reason could not be treated with LPV/r.
Cachexia, defined as an Body Mass Index <17 Kg/m2.
Pregnant or breastfeeding women, or women of childbearing potential who do not use the appropriate contraceptive method, according to the Investigator judgment.
Clinically relevant disease or condition, according to the Investigator judgment, three months prior to the patient inclusion in the Study.
Patients taking the following concomitant medication that could affect the adipocyte function or morphology, such as: insulin, steroids, anabolic steroid, anti-inflammatory medication for more than three months.

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: NCT01031849

Locations


Spain
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Clínico San Carlos
Madrid, Spain, 28040

Sponsors and Collaborators

Ines Perez

Investigators


Principal Investigator:	Vicente Estrada, MD	hospital Clínico San Carlos, Madrid

More Information


Responsible Party:	Ines Perez, MD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:	NCT01031849 History of Changes
Other Study ID Numbers:	HCSKAL-2009-01 2009-016090-14 ( Other Identifier: EudraCT Number )
Study First Received:	December 4, 2009
Last Updated:	April 5, 2013

Keywords provided by Ines Perez, Hospital San Carlos, Madrid:


HIV 1 patients

Additional relevant MeSH terms:


Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases	Ritonavir Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017

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