HIV Infections
Conditions
Keywords
HIV 1 patients
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®)
Interventions
DRUGKaletra
Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid.
Sponsors
Ines Perez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
Spain
Outcome results
None listed