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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)

This study is currently recruiting participants.
Verified April 2011 by Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor:
Information provided by:
Asociacion para el Estudio de las Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT01060618
First received: January 31, 2010
Last updated: April 20, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Other: Maraviroc + Trofile ESTA® (diagnose test)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Further study details as provided by Asociacion para el Estudio de las Enfermedades Infecciosas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety assessment throughout the Study [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Maraviroc effects assessment in the drug-resistance evolution in naïve patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Tropism changes assessment since the Screening period [ Time Frame: 1 month per patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: May 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060618

Contacts
Contact: Santiago Moreno, MD +34 913368710 smoreno.hrc@salud.madrid.org

Locations
Spain
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Santiago Moreno, MD     +34 913368710     smoreno.hrc@salud.madrid.org    
Contact: Beatriz Hernández, BSc     +34 913368711     bhernandeznovoa@gmail.com    
Principal Investigator: Santiago Moreno, MD            
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Rafael Rubio, MD            
Principal Investigator: Rafel Rubio, MD            
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Juan González, MD            
Principal Investigator: Juan González, MD            
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 280007
Contact: Juan C. López Bernaldo de Quirós, MD            
Principal Investigator: Juan C. López Bernaldo de Quirós            
Sponsors and Collaborators
Asociacion para el Estudio de las Enfermedades Infecciosas
Investigators
Principal Investigator: Santiago Moreno, MD Hospital Ramón y Cajal, Madrid
  More Information

No publications provided

Responsible Party: Dr. Santiago Moreno, Hospital Ramón y Cajal
ClinicalTrials.gov Identifier: NCT01060618     History of Changes
Other Study ID Numbers: TROPISMVC, 2008-007208-28
Study First Received: January 31, 2010
Last Updated: April 20, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 17, 2012