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

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ClinicalTrials.gov Identifier: NCT01031849
Recruitment Status : Terminated (patient sample not reached)
First Posted : December 15, 2009
Last Update Posted : April 8, 2013
Information provided by (Responsible Party):
Ines Perez, Hospital San Carlos, Madrid

December 4, 2009
December 15, 2009
April 8, 2013
February 2010
October 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01031849 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir
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
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®)
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
HIV Infections
Drug: Kaletra
Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.
Experimental: Kaletra, all patients
Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day
Intervention: Drug: Kaletra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2012
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2009-016090-14 ( Other Identifier: EudraCT Number )
Not Provided
Not Provided
Ines Perez, Hospital San Carlos, Madrid
Ines Perez
Not Provided
Principal Investigator: Vicente Estrada, MD hospital Clínico San Carlos, Madrid
Hospital San Carlos, Madrid
April 2013

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