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 (TROPISMVC)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Asociacion para el Estudio de las Enfermedades Infecciosas

ClinicalTrials.gov Identifier:

NCT01060618

First received: January 31, 2010

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 31, 2010

Last Updated Date

February 27, 2013

Start Date ^ICMJE

May 2009

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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) [ Time Frame: 10 days of treatment per patient ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01060618 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed). [ Time Frame: 1 month per patient ] [ Designated as safety issue: No ]
To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study. [ Time Frame: 1 month per patient ] [ Designated as safety issue: No ]
Safety assessment throughout the Study [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Maraviroc effects assessment in the drug-resistance evolution in naïve patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Tropism changes assessment since the Screening period [ Time Frame: 1 month per patient ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Maraviroc + Trofile ESTA®

the patients have the Trofile ESTA® test performed and sent for evaluation. Once the results are obtained (about 1 month later), the patients take the medication Maraviroc during ten days. The viral load assessment throughout the Study help to make a prediction to assess if the patients would have a positive response Vs. CCR5 antagonist of a negative response

Intervention: Other: Maraviroc + Trofile ESTA® (diagnose test)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01060618

Other Study ID Numbers ^ICMJE

TROPISMVC, 2008-007208-28

Has Data Monitoring Committee

Responsible Party

Asociacion para el Estudio de las Enfermedades Infecciosas

Study Sponsor ^ICMJE

Asociacion para el Estudio de las Enfermedades Infecciosas

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Santiago Moreno, MD

Hospital Universitario Ramon y Cajal

Information Provided By

Asociacion para el Estudio de las Enfermedades Infecciosas

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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