Clinical trial NCT01031849: Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV 1 patients
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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®)


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 48 and 96 weeks
Secondary outcomes:
measure: Changes in physical fat deposits
timeFrame: Baseline, 24, 48, 72 and 96 weeks
measure: Changes in leptine and adiponectine plasma levels
timeFrame: baseline, 24, 48, 72 and 96 weeks
measure: Patients percentage with virologic response (ARN-VIH< 50 copies/mL)
timeFrame: 48 and 96 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: hospital Clínico San Carlos, Madrid
name: Vicente Estrada, MD
role: PRINCIPAL_INVESTIGATOR
References: