Clinical trial NCT01060618: 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: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2010-02-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: 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)
timeFrame: 10 days of treatment per patient
Secondary outcomes:
measure: To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed).
timeFrame: 1 month per patient
measure: To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study.
timeFrame: 1 month per patient
measure: Safety assessment throughout the Study
timeFrame: 12 months
measure: Maraviroc effects assessment in the drug-resistance evolution in naïve patients
timeFrame: 12 months
measure: Tropism changes assessment since the Screening period
timeFrame: 1 month per patient
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Santiago Moreno, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.