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)

Asociacion para el Estudio de las Enfermedades Infecciosas

Status and phase: Completed; Phase 3; Phase 2

Conditions: HIV Infections

Treatments: Other: Maraviroc + Trofile ESTA® (diagnose test)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01060618

TROPISMVC

2008-007208-28 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Maraviroc + Trofile ESTA®

Experimental group

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

Treatment:

Other: Maraviroc + Trofile ESTA® (diagnose test)