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

Study Overview
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Maraviroc + Trofile ESTA® (diagnose test)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maraviroc + Trofile ESTA®<br>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 | Other: Maraviroc + Trofile ESTA® (diagnose test)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |