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Etravirine Plus 2 Analogs in HIV-infected Patients

NCT ID: NCT01437241

Last Updated: 2011-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV-1-infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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etravirine

Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role lead

Responsible Party

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Luis F. Lopez-Cortes

M.d., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis F Lopez-Cortes, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Hospitales Universitarios Virgen del Rocio

Francisco Tellez-Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de la Linea de la Concepcion

Antonio Vergara-Campos, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Puerto Real

Milagros Garcia-Lazaro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofia de Cordoba

Jose Hernandez-Quero, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario San Cecilio

Juan Pascuau-Liaño, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Virgen de las Nieves

Miguel A Lopez-Ruz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Virgen de las Nieves

Mohamed O Mohamed-Balghata, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ciudad de Jaén

Dr.Javier de la Torre-Lima, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Costa del Sol

Manuel Marquez Solero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Victoria

Marcial delgado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Carlos Haya

Fernando Lozano-León, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Valme

Locations

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Hospital La Linea de la Concepción

La Linea de La Concepción, Cadiz, Spain

Site Status

Hospital Universitario Puerto Real

Puerto Real, Cadiz, Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, Cordoba, Spain

Site Status

Hospital Universitario San Cecilio

Granada, Granada, Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Site Status

Hospital Ciudad de Jaén

Jaén, Jaen, Spain

Site Status

Hospital Costa del Sol

Marbella, Malaga, Spain

Site Status

Hospital Universitario Carlos Haya

Málaga, Malaga, Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, Sevilla, Spain

Site Status

Hospital Universitario Virgen de Valme

Seville, Sevilla, Spain

Site Status

Countries

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Spain

References

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Lopez-Cortes LF, Viciana P, Giron-Gonzalez JA, Romero-Palacios A, Marquez-Solero M, Martinez-Perez MA, Lopez-Ruz MA, de la Torre-Lima J, Tellez-Perez F, Delgado-Fernandez M, Garcia-Lazaro M, Lozano F, Mohamed-Balghata MO; Sociedad Andaluza de Enfermedades Infecciosas. Clinical and virological efficacy of etravirine plus two active Nucleos(t)ide analogs in an heterogeneous HIV-infected population. PLoS One. 2014 May 16;9(5):e97262. doi: 10.1371/journal.pone.0097262. eCollection 2014.

Reference Type DERIVED
PMID: 24836963 (View on PubMed)

Other Identifiers

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LFL-ETR-2010-01

Identifier Type: -

Identifier Source: org_study_id