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The purpose of this study is to evaluate the virological and clinical efficacy of etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) in HIV-infected patients. Additionally, the safety of these regimens, specially lipid profiles, will be assessed.
Methods: prospective, single arm multicenter clinical trial without entry restrictions on plasma HIV-RNA (VL) or CD4 with a planned duration of 52 weeks.
The primary clinical endpoint is the percentage of subjects with therapeutic success on etravirine 400 mg/day (200 mg bid or 400 mg qd) plus 2 active NRTIs after 12 months. Efficacy data will be analyzed by on-treatment and by intention-to-treat analyses (noncomplete/missing equals failure), considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to less than 50 copies/ml after 24 weeks on treatment or a confirmed VL of more than 200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion.
Patients missing two consecutive scheduled visits were considered lost to follow-up. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
NRTIs prescribed as part of HAART were selected by the responsible physicians on the basis of previous antiretroviral treatments and/or genotypic resistance testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etravirine | Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) |
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| Measure | Description | Time Frame |
|---|---|---|
| Virological efficacy | Percentage of subjects with therapeutic success at month 12. Efficacy data will be analyzed by on-treatment and by intention-to-treat considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to <50 copies/ml after 24 weeks or a confirmed VL of >200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion. Patients missing two consecutive scheduled visits were considered lost to follow-up. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected patients who strated an antirretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010
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| Name | Affiliation | Role |
|---|---|---|
| Luis F Lopez-Cortes, MD, PhD. | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Francisco Tellez-Perez, MD | Hospital de la Linea de la Concepcion | Principal Investigator |
| Antonio Vergara-Campos, MD, PhD. | Hospital Universitario de Puerto Real | Principal Investigator |
| Milagros Garcia-Lazaro, MD | Hospital Universitario Reina Sofia de Cordoba | Principal Investigator |
| Jose Hernandez-Quero, MD, PhD. | Hospital Universitario San Cecilio | Principal Investigator |
| Juan Pascuau-Liaño, MD, PhD. | University Hospital Virgen de las Nieves | Principal Investigator |
| Miguel A Lopez-Ruz, MD, PhD | University Hospital Virgen de las Nieves | Principal Investigator |
| Mohamed O Mohamed-Balghata, MD | Hospital Universitario Ciudad de Jaén | Principal Investigator |
| Dr.Javier de la Torre-Lima, MD, PhD | Hospital Costa del Sol |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Linea de la Concepción | La Linea de La Concepción | Cadiz | 11300 | Spain | ||
| Hospital Universitario Puerto Real |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24836963 | Derived | Lopez-Cortes LF, Viciana P, Giron-Gonzalez JA, Romero-Palacios A, Marquez-Solero M, Martinez-Perez MA, Lopez-Ruz MA, de la Torre-Lima J, Tellez-Perez F, Delgado-Fernandez M, Garcia-Lazaro M, Lozano F, Mohamed-Balghata MO; Sociedad Andaluza de Enfermedades Infecciosas. Clinical and virological efficacy of etravirine plus two active Nucleos(t)ide analogs in an heterogeneous HIV-infected population. PLoS One. 2014 May 16;9(5):e97262. doi: 10.1371/journal.pone.0097262. eCollection 2014. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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plasma
| Principal Investigator |
| Manuel Marquez Solero, MD | Hospital Universitario Virgen de la Victoria | Principal Investigator |
| Marcial delgado, MD | Hospital Universitario Carlos Haya | Principal Investigator |
| Fernando Lozano-León, MD, PhD. | Hospital Universitario de Valme | Principal Investigator |
| Puerto Real |
| Cadiz |
| 11510 |
| Spain |
| Hospital Universitario Reina Sofía | Córdoba | Cordoba | 14004 | Spain |
| Hospital Universitario San Cecilio | Granada | Granada | 04009 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| Hospital Ciudad de Jaén | Jaén | Jaen | 23001 | Spain |
| Hospital Costa del Sol | Marbella | Malaga | 29600 | Spain |
| Hospital Universitario Carlos Haya | Málaga | Malaga | 29010 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Malaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Sevilla | 41013 | Spain |
| Hospital Universitario Virgen de Valme | Seville | Sevilla | 41014 | Spain |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |