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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

NCT ID: NCT01060618

Last Updated: 2013-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Maraviroc + Trofile ESTA® (diagnose test)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociacion para el Estudio de las Enfermedades Infecciosas

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Santiago Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Locations

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Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Site Status

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Cascajero A, Rastrojo A, Diez-Fuertes F, Hernandez-Novoa B, Aguado B, Moreno S, Alcami J, Perez-Olmeda M. Deep-Sequencing Analysis of the Dynamics of HIV-1 Quasiespecies in Naive Patients during a Short Exposure to Maraviroc. J Virol. 2018 May 14;92(11):e00390-18. doi: 10.1128/JVI.00390-18. Print 2018 Jun 1.

Reference Type DERIVED
PMID: 29563289 (View on PubMed)

Hernandez-Novoa B, Madrid-Elena N, Dronda F, Perez-Elias MJ, Casado JL, Perez-Molina JA, Moreno A, Estebanez M, Gonzalez J, Zamora J, Moreno S. Virological response to short-course maraviroc monotherapy does not predict viral tropism in HIV-1-infected treatment-naive patients. J Antimicrob Chemother. 2014 Jul;69(7):1916-9. doi: 10.1093/jac/dku059. Epub 2014 Mar 12.

Reference Type DERIVED
PMID: 24623833 (View on PubMed)

Other Identifiers

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2008-007208-28

Identifier Type: OTHER

Identifier Source: secondary_id

TROPISMVC

Identifier Type: -

Identifier Source: org_study_id