Clinical trial NCT01437241: Etravirine Plus 2 Analogs in HIV-infected Patients
Official title: Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Keywords: HIV-infection
Etravirine
Treatment
Non-nucleoside reverse-transcriptase inhibitor
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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.

Primary outcomes:
measure: Virological efficacy
timeFrame: 52 weeks
Secondary outcomes:
measure: Safety
timeFrame: 52 weeks
Other outcomes:
Locations:
city: La Linea de la Concepción
country: Spain
facility: Hospital La Linea de la Concepción
state: Cadiz
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
state: Cadiz
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Malaga
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Jaen
country: Spain
facility: Hospital Ciudad de Jaén
city: Malaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocio
name: Luis F Lopez-Cortes, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de la Linea de la Concepcion
name: Francisco Tellez-Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Puerto Real
name: Antonio Vergara-Campos, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Reina Sofia de Cordoba
name: Milagros Garcia-Lazaro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario San Cecilio
name: Jose Hernandez-Quero, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Virgen de las Nieves
name: Juan Pascuau-Liaño, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Virgen de las Nieves
name: Miguel A Lopez-Ruz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ciudad de Jaén
name: Mohamed O Mohamed-Balghata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Costa del Sol
name: Dr.Javier de la Torre-Lima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen de la Victoria
name: Manuel Marquez Solero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Carlos Haya
name: Marcial delgado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Valme
name: Fernando Lozano-León, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.