Double-method Comparative Study in Order to Predict the Use of Co-receptors From Type 1 HIV: Phenotypic Study (Trofile ESTA®) and Virologic Response to a CCR5 Antagonist in the Short Term

HIV Infections Clinical Trial

— TROPISMVC  

Official title:

Estudio Comparativo de Dos métodos Para Predecir el Uso de Co-receptores Por el Virus de la Inmunodeficiencia 1 (HIV-1): el Ensayo fenotípico (Trofile ESTA®) y la Respuesta virológica a Corto Plazo a un Antagonista de CCR5

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060618
• Other study ID #: TROPISMVC
• Secondary ID: 2008-007208-28
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 31, 2010
• Last updated: February 27, 2013
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: Asociacion para el Estudio de las Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The summary of the Study is to compare two methods in order to predict how the 1-HIV will use a co-receptor: the use of an accredited test (TROFILE ESTA®) and the viral response to a CCR5 antagonist in the short term.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients willing to give, sign and date the Informed Consent Form to participate in the Study and to donate their samples for cell and molecular Studies, after receiving the appropriate information about the Study design, the main objective of the Study and the potential risks.

• Patients aged >18.

• Patients with chronic HIV infection

• Patients with no previous HAART (naïve patients).

• Patients that do not meet HAART starting criteria.

• Viral load >1.000 HIV RNA copies/mL

• Patients able to understand the Study objectives and able to perform frequent visits to the Study Site.

Exclusion Criteria:

• Prior HAART (regardless of the HAART type).

• Pregnancy or willingness to get pregnant during the Study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Maraviroc + Trofile ESTA® (diagnose test)
The Trofile ESTA® will be performed in those patients and once the results are obtained (within one month approximately), the patients will be treated with the medication Maraviroc

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion para el Estudio de las Enfermedades Infecciosas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if there is a correlation between the Trofile ESTA® test for viral tropism and the viral load reduction after a short treatment with maraviroc in naïve patients (patients with no previous HAART)		10 days of treatment per patient	No
Secondary	To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed).		1 month per patient	No
Secondary	To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study.		1 month per patient	No
Secondary	Safety assessment throughout the Study		12 months	Yes
Secondary	Maraviroc effects assessment in the drug-resistance evolution in naïve patients		12 months	Yes
Secondary	Tropism changes assessment since the Screening period		1 month per patient	No