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

Phase 4

Terminated

• Conditions: HIV Infections
• Interventions: Drug: Kaletra

• Registration Number: NCT01031849
• Lead Sponsor: Ines Perez

Brief 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®)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Study Start: 2010-02
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kaletra, all patients	Kaletra	Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain