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

Ines Perez

Status and phase: Terminated; Phase 4

Conditions: HIV Infections

Treatments: Drug: Kaletra

Study type: Interventional

Funder types: Other

Identifiers

NCT01031849

2009-016090-14 (Other Identifier)

HCSKAL-2009-01

Details and patient eligibility

About

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®)

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

7 participants in 1 patient group

Kaletra, all patients

Experimental group

Description:

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

Treatment:

Drug: Kaletra