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
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
2 other identifiers
interventional
58
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started May 2009
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 31, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 28, 2013
February 1, 2013
2.6 years
January 31, 2010
February 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
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
To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study.
1 month per patient
Safety assessment throughout the Study
12 months
Maraviroc effects assessment in the drug-resistance evolution in naïve patients
12 months
Tropism changes assessment since the Screening period
1 month per patient
Study Arms (1)
Maraviroc + Trofile ESTA®
EXPERIMENTALthe 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior HAART (regardless of the HAART type).
- Pregnancy or willingness to get pregnant during the Study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 280007, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Related Publications (2)
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.
PMID: 29563289DERIVEDHernandez-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.
PMID: 24623833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Santiago Moreno, MD
Hospital Universitario Ramon y Cajal
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2010
First Posted
February 2, 2010
Study Start
May 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 28, 2013
Record last verified: 2013-02