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

HIV Infections Clinical Trial

— BIOKAL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01031849
• Other study ID #: HCSKAL-2009-01
• Secondary ID: 2009-016090-14
• Status: Terminated
• Phase: Phase 4
• First received: December 4, 2009
• Last updated: April 5, 2013
• Start date: February 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2013
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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®)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ines Perez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Changes in physical fat deposits		Baseline, 24, 48, 72 and 96 weeks	No
Secondary	Changes in leptine and adiponectine plasma levels		baseline, 24, 48, 72 and 96 weeks	No
Secondary	Patients percentage with virologic response (ARN-VIH< 50 copies/mL)		48 and 96 weeks	No