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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060618
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
Asociacion para el Estudio de las Enfermedades Infecciosas

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.

Condition or disease Intervention/treatment Phase
HIV Infections Other: Maraviroc + Trofile ESTA® (diagnose test) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : May 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc

Arm Intervention/treatment
Experimental: Maraviroc + Trofile ESTA®
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)
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

Primary Outcome Measures :
  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) [ Time Frame: 10 days of treatment per patient ]

Secondary Outcome Measures :
  1. To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed). [ Time Frame: 1 month per patient ]
  2. To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study. [ Time Frame: 1 month per patient ]
  3. Safety assessment throughout the Study [ Time Frame: 12 months ]
  4. Maraviroc effects assessment in the drug-resistance evolution in naïve patients [ Time Frame: 12 months ]
  5. Tropism changes assessment since the Screening period [ Time Frame: 1 month per patient ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01060618

Hospital General Universitario Gregorio Marañón
Madrid, Spain, 280007
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Asociacion para el Estudio de las Enfermedades Infecciosas
Principal Investigator: Santiago Moreno, MD Hospital Universitario Ramon y Cajal

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Asociacion para el Estudio de las Enfermedades Infecciosas Identifier: NCT01060618     History of Changes
Other Study ID Numbers: TROPISMVC
2008-007208-28 ( Other Identifier: EudraCT Number (EMEA) )
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents