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

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®)

Study Overview

• Status: Terminated
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Kaletra

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	48 and 96 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ines Perez
• Investigators: Principal Investigator: Vicente Estrada, MD, Hospital Clínico San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: HIV 1 patients
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: HCSKAL-2009-01; 2009-016090-14 (Other Identifier: EudraCT Number)