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Completed

NCT Number: NCT01060618

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital General Universitario Gregorio Marañón, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maraviroc + Trofile ESTA® (diagnose test)

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

Network

Registry information

Official study 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

Acronym: TROPISMVC

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2010
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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