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
  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
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
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 Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario San Cecilio
Granada, Spain, 04009
Hospital Ciudad de Jaén
Jaen, Spain, 23001
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital Universitario Carlos Haya
Malaga, Spain, 29010
Hospital Universitario Virgen de Valme
Sevilla, Spain, 41014
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
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

No publications provided

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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014