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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)

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011868-11-ES
Enrollment
Unknown
Registered
2009-04-29
Start date
2009-07-30
Completion date
Unknown
Last updated
2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection MedDRA version: 9.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection

Interventions

Trade Name: CELSENTRI 300 mg comprimidos recubiertos con película Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MARAVIROC Other descriptive name: MARAVIROC Concentration unit: mg millig

Sponsors

Lluita contra la Sida Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the rates of virological suppression 50 copies in 2 determinations within 1 month. The first date with VL > 50 will be used to calculate time to virological failure. ? To determine the changes in cardiovascular risk. ? To determine the changes in CD4 and CD8 +T cell counts. ? To determine changes in the proportion of adverse events drug-related ? To assess changes in genotype test and in viral tropism in patient on viral failure.;Primary end point(s): The primary endpoint is the percentage of patients who experienced virological failure at week 48.—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026