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)
Information provided by (Responsible Party):
Ines Perez, Hospital San Carlos, Madrid
First received: December 4, 2009
Last updated: April 5, 2013
Last verified: April 2013
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®)
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
||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
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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Experimental: Kaletra, all patients
Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day
Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01031849
|Fundación Jiménez Díaz
|Madrid, Spain, 28040 |
|Hospital Clínico San Carlos
|Madrid, Spain, 28040 |
||Vicente Estrada, MD
||hospital Clínico San Carlos, Madrid
No publications provided
||Ines Perez, MD, Hospital San Carlos, Madrid
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 4, 2009
||April 5, 2013
||Spain: Spanish Agency of Medicines
Keywords provided by Hospital San Carlos, Madrid:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action