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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Asociacion para el Estudio de las Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT01060618
First received: January 31, 2010
Last updated: February 27, 2013
Last verified: February 2013

January 31, 2010
February 27, 2013
May 2009
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01060618 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
HIV Infections
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
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
Intervention: Other: Maraviroc + Trofile ESTA® (diagnose test)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01060618
TROPISMVC, 2008-007208-28
No
Asociacion para el Estudio de las Enfermedades Infecciosas
Asociacion para el Estudio de las Enfermedades Infecciosas
Not Provided
Principal Investigator: Santiago Moreno, MD Hospital Universitario Ramon y Cajal
Asociacion para el Estudio de las Enfermedades Infecciosas
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP