Etravirine Plus 2 Analogs in HIV-infected Patients

NCT01437241 | Completed DMC

• 1 other identifier: LFL-ETR-2010-01
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

HIV-1-infection

Keywords

HIV-infection; Etravirine; Treatment; Non-nucleoside reverse-transcriptase inhibitor

Outcome Measures

Primary Outcomes (1)

• Virological efficacy

  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.

  52 weeks

Secondary Outcomes (1)

• Safety

  52 weeks

Study Arms (1)

etravirine

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (11)

Hospital La Linea de la Concepción

La Linea de La Concepción, Cadiz, 11300, Spain

Location

Hospital Universitario Puerto Real

Puerto Real, Cadiz, 11510, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Cordoba, 14004, Spain

Location

Hospital Universitario San Cecilio

Granada, Granada, 04009, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital Ciudad de Jaén

Jaén, Jaen, 23001, Spain

Location

Hospital Costa del Sol

Marbella, Malaga, 29600, Spain

Location

Hospital Universitario Carlos Haya

Málaga, Malaga, 29010, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Sevilla, 41013, Spain

Location

Hospital Universitario Virgen de Valme

Seville, Sevilla, 41014, Spain

Location

Related Publications (1)

• 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.

  PMID: 24836963 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.d., Ph.D.

Study Record Dates

• First Submitted: September 17, 2011
• First Posted: September 20, 2011
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 1, 2011

Record last verified: 2011-10

Locations

ES (11)