Etravirine Plus 2 Analogs in HIV-infected Patients
This study has been completed.
Sponsor:
Hospitales Universitarios Virgen del Rocío
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
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Purpose
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.
| Condition |
|---|
|
HIV-1-infection |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Hospitales Universitarios Virgen del Rocío:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
Biospecimen Retention: Samples Without DNA
plasma
| Enrollment: | 175 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
etravirine
Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs)
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-infected patients who strated an antirretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437241
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437241
Locations
| 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 | |
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Investigators
| 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 |
More Information
| 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 |
| Study First Received: | September 17, 2011 |
| Last Updated: | October 30, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospitales Universitarios Virgen del Rocío:
|
HIV-infection Etravirine Treatment Non-nucleoside reverse-transcriptase inhibitor |
Additional relevant MeSH terms:
|
Etravirine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 30, 2016