Status:
COMPLETED
Etravirine Plus 2 Analogs in HIV-infected Patients
Lead Sponsor:
Hospitales Universitarios Virgen del Rocío
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-80 years
Brief Summary
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...
Detailed Description
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 percenta...
Eligibility Criteria
Inclusion
- Older than 18 years, starting an antiretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010, evidence of activity of all drugs on the basis of treatment history and genotypic resistance testing, informed consent, and at least one follow-up visit.
Exclusion
- Genotypic resistance tests with evidence of resistance to any drug used, and concomitant use of drugs with potentially adverse interactions with etravirine pharmacokinetics, such as rifampin.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01437241
Start Date
January 1 2009
End Date
September 1 2011
Last Update
November 1 2011
Active Locations (11)
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1
Hospital La Linea de la Concepción
La Linea de La Concepción, Cadiz, Spain, 11300
2
Hospital Universitario Puerto Real
Puerto Real, Cadiz, Spain, 11510
3
Hospital Universitario Reina Sofía
Córdoba, Cordoba, Spain, 14004
4
Hospital Universitario San Cecilio
Granada, Granada, Spain, 04009