Etravirine Plus 2 Analogs in HIV-infected Patients
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| ClinicalTrials.gov Identifier: NCT01437241 |
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Recruitment Status
:
Completed
First Posted
: September 20, 2011
Last Update Posted
: November 1, 2011
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| Condition or disease |
|---|
| HIV-1-infection |
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.
| Study Type : | Observational |
| Actual Enrollment : | 175 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | September 2011 |
| Group/Cohort |
|---|
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etravirine
Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs)
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- Virological efficacy [ Time Frame: 52 weeks ]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.
- Safety [ Time Frame: 52 weeks ]The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437241
| Spain | |
| Hospital La Linea de la Concepción | |
| La Linea de la Concepción, Cadiz, Spain, 11300 | |
| Hospital Universitario Puerto Real | |
| Puerto Real, Cadiz, Spain, 11510 | |
| Hospital Costa del Sol | |
| Marbella, Malaga, Spain, 29600 | |
| Hospital Universitario Reina Sofía | |
| Cordoba, Spain, 14004 | |
| Hospital Universitario San Cecilio | |
| Granada, Spain, 04009 | |
| Hospital Universitario Virgen de las Nieves | |
| Granada, Spain, 18014 | |
| Hospital Ciudad de Jaén | |
| Jaen, Spain, 23001 | |
| Hospital Universitario Carlos Haya | |
| Malaga, Spain, 29010 | |
| Hospital Universitario Virgen de la Victoria | |
| Malaga, Spain, 29010 | |
| Hospital Universitario Virgen del Rocio | |
| Sevilla, Spain, 41013 | |
| Hospital Universitario Virgen de Valme | |
| Sevilla, Spain, 41014 | |
| 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 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 | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Luis F. Lopez-Cortes, M.d., Ph.D., Hospitales Universitarios Virgen del Rocío |
| ClinicalTrials.gov Identifier: | NCT01437241 History of Changes |
| Other Study ID Numbers: |
LFL-ETR-2010-01 |
| First Posted: | September 20, 2011 Key Record Dates |
| Last Update Posted: | November 1, 2011 |
| Last Verified: | October 2011 |
Keywords provided by Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío:
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HIV-infection Etravirine Treatment Non-nucleoside reverse-transcriptase inhibitor |
Additional relevant MeSH terms:
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Reverse Transcriptase Inhibitors Etravirine Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |