Etravirine Plus 2 Analogs in HIV-infected Patients

Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection

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.

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• Spain
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • Granada, Spain, 04009
    • Hospital Universitario San Cecilio
  • Jaen, Spain, 23001
    • Hospital Ciudad de Jaén
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Malaga, Spain, 29010
    • Hospital Universitario Carlos Haya
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme
  • Cadiz
    • La Linea de la Concepción, Cadiz, Spain, 11300
      • Hospital La Linea de la Concepción
    • Puerto Real, Cadiz, Spain, 11510
      • Hospital Universitario Puerto Real
  • Malaga
    • Marbella, Malaga, Spain, 29600
      • Hospital Costa del Sol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.	52 weeks

Collaborators and Investigators

• Sponsor: Hospitales Universitarios Virgen del Rocío
• Investigators: Principal Investigator: Luis F Lopez-Cortes, MD, PhD., Hospitales Universitarios Virgen del Rocío; 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 Jaen; 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 17, 2011
• First Submitted That Met QC Criteria: September 19, 2011
• First Posted (Estimate): September 20, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2011
• Last Update Submitted That Met QC Criteria: October 30, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Treatment; Etravirine; HIV-infection; Non-nucleoside reverse-transcriptase inhibitor
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: LFL-ETR-2010-01