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

Tracking Information

First Received Date ^ICMJE

December 4, 2009

Last Updated Date

April 5, 2013

Start Date ^ICMJE

February 2010

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01031849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in physical fat deposits [ Time Frame: Baseline, 24, 48, 72 and 96 weeks ] [ Designated as safety issue: No ]
Changes in leptine and adiponectine plasma levels [ Time Frame: baseline, 24, 48, 72 and 96 weeks ] [ Designated as safety issue: No ]
Patients percentage with virologic response (ARN-VIH< 50 copies/mL) [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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®)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Kaletra

Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.

Study Arm (s)

Experimental: Kaletra, all patients

Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day

Intervention: Drug: Kaletra

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01031849

Other Study ID Numbers ^ICMJE

HCSKAL-2009-01, 2009-016090-14

Has Data Monitoring Committee

Responsible Party

Ines Perez, Hospital San Carlos, Madrid

Study Sponsor ^ICMJE

Ines Perez

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Vicente Estrada, MD

hospital Clínico San Carlos, Madrid

Information Provided By

Hospital San Carlos, Madrid

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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