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

NCT01031849 | Terminated Phase 4

• 2 other identifiers: HCSKAL-2009-012009-016090-14
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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®)

Conditions

HIV Infections

Keywords

HIV 1 patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Kaletra, all patients

EXPERIMENTAL

Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day

Drug: Kaletra

Interventions

Kaletra DRUG

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

Kaletra, all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ines Perez: lead

Study Sites (2)

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Vicente Estrada, MD

  hospital Clínico San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 15, 2009
• Study Start: February 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

ES (2)