ENSAYO CLÍNICO PILOTO PARA EVALUAR LA SEGURIDAD Y EFICACIA DE CAMBIAR EL ITINAN O EL IP A MARAVIROC EN PACIENTES INFECTADOS POR EL VIH-1 CON CARGA VIRAL INDETECTABLE Y DISLIPEMIA ASOCIADA A LOS ANTIRETROVIRALES (PILOT STUDY TO ASSESS THE SAFETY AND EFICACY OF SWITCHING THE NNRTI OR PI TO MARAVIROC IN HIV-1-INFECTED SUBJECTS WITH PERSISTENT VIREMIA SUPPRESSION EXPERIENCING NNRTI OR PI-RELATED DYSLIPEMIA)

• Conditions: HIV Infection; MedDRA version: 9.1Level: LLTClassification code 10008919Term: Chronic HIV infection

• Registration Number: EUCTR2009-011868-11-ES
• Lead Sponsor: luita contra la Sida Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-29
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patient having a diagnosis of HIV infection, on stable HAART including: 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz)
- Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
- Dyslipemia (LDL cholesterol >130 mg/dL or triglycerides > 350 mg/dL) derived from their current PI or NNRTI regimen.
- Nadir CD4 cell count > 350 cells/mm3.
- Availability of a pre-treatment sample with an R5 virus by ES-Trofile.
- Absence of X4 viruses in PBMCs immediately before treatment switch.
- Absence of resistance mutations in the RT or PR by (TrugeneTM)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Virologic failure to a previous antiretroviral regimen.
- Presence of blips in previous assessments of viral load while on HAART.
- Any antiretroviral resistance mutation in a previous resistance test.
- Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified