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Etravirine Plus 2 Analogs in HIV-infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01437241
First received: September 17, 2011
Last updated: October 30, 2011
Last verified: October 2011

September 17, 2011
October 30, 2011
January 2009
July 2011   (final data collection date for primary outcome measure)
Virological efficacy [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01437241 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
Same as current
Not Provided
Not Provided
 
Etravirine Plus 2 Analogs in HIV-infected Patients
Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma

Non-Probability Sample

HIV-infected patients who strated an antirretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010

HIV-1-infection
Not Provided
etravirine
Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
September 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01437241
LFL-ETR-2010-01
Yes
Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
Hospitales Universitarios Virgen del Rocío
Not Provided
Principal Investigator: Luis F Lopez-Cortes, MD, PhD. Hospitales Universitarios Virgen del Rocio
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
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
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
Hospitales Universitarios Virgen del Rocío
October 2011

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