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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01060618

Acronym

TROPISMVC

Enrollment

Registered

2010-02-02

Start date

2009-05-31

Completion date

2011-12-31

Last updated

2013-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

OTHERMaraviroc + 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 design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026