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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007208-28 | Other Identifier | EudraCT Number (EMEA) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc + Trofile ESTA® | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 10 days of treatment per patient |
| Measure | Description | Time Frame |
|---|---|---|
| To establish a viral load reduction cut point, which would differentiate R5-tropic virus from non-R5 tropic virus(X4/dual/mixed). | 1 month per patient | |
| To assess the viral response to a CCR5 antagonist according to the viral tropism identified in the phenotypic Study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Moreno, MD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Gregorio Marañón | Madrid | Madrid | 280007 | Spain | ||
| Hospital Ramón y Cajal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29563289 | Derived | Cascajero A, Rastrojo A, Diez-Fuertes F, Hernandez-Novoa B, Aguado B, Moreno S, Alcami J, Perez-Olmeda M. Deep-Sequencing Analysis of the Dynamics of HIV-1 Quasiespecies in Naive Patients during a Short Exposure to Maraviroc. J Virol. 2018 May 14;92(11):e00390-18. doi: 10.1128/JVI.00390-18. Print 2018 Jun 1. | |
| 24623833 | Derived |
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| 1 month per patient |
| Safety assessment throughout the Study | 12 months |
| Maraviroc effects assessment in the drug-resistance evolution in naïve patients | 12 months |
| Tropism changes assessment since the Screening period | 1 month per patient |
| Madrid |
| Madrid |
| 28034 |
| Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hernandez-Novoa B, Madrid-Elena N, Dronda F, Perez-Elias MJ, Casado JL, Perez-Molina JA, Moreno A, Estebanez M, Gonzalez J, Zamora J, Moreno S. Virological response to short-course maraviroc monotherapy does not predict viral tropism in HIV-1-infected treatment-naive patients. J Antimicrob Chemother. 2014 Jul;69(7):1916-9. doi: 10.1093/jac/dku059. Epub 2014 Mar 12. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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