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


Further study details as provided by 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 ] [ 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 ]

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
Genders Eligible for Study:   Both
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
Hospital Clínico San Carlos
Madrid, Spain, 28040
Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Ines Perez
Investigators
Principal Investigator: Vicente Estrada, MD hospital Clínico San Carlos, Madrid
  More Information

No publications provided

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
Study First Received: December 4, 2009
Last Updated: April 5, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital San Carlos, Madrid:
HIV 1 patients

Additional relevant MeSH terms:
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
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014