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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 (TROPISMVC)

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Maraviroc + Trofile ESTA® (diagnose test)

About this trial

This is an interventional diagnostic trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital General Universitario Gregorio Marañón
Hospital Ramón y Cajal
Hospital Universitario 12 de Octubre
Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maraviroc + Trofile ESTA®

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed).

To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study.

Safety assessment throughout the Study

Maraviroc effects assessment in the drug-resistance evolution in naïve patients

Tropism changes assessment since the Screening period

Full Information

NCT ID

NCT01060618

First Posted

January 31, 2010

Last Updated

February 27, 2013

Sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

1. Study Identification

Unique Protocol Identification Number

NCT01060618

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Maraviroc + Trofile ESTA®

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Maraviroc + Trofile ESTA® (diagnose test)

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

10 days of treatment per patient

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Safety assessment throughout the Study

Time Frame

12 months

Title

Maraviroc effects assessment in the drug-resistance evolution in naïve patients

Time Frame

12 months

Title

Tropism changes assessment since the Screening period

Time Frame

1 month per patient

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Santiago Moreno, MD

Organizational Affiliation

Hospital Universitario Ramon y Cajal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital General Universitario Gregorio Marañón

City

Madrid

ZIP/Postal Code

280007

Country

Spain

Facility Name

Hospital Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

29563289

Citation

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.

Results Reference

derived

PubMed Identifier

24623833

Citation

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.

Results Reference

derived

Learn more about this trial

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

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