Etravirine Plus 2 Analogs in HIV-infected Patients
- Conditions
- HIV-1-infection
- Registration Number
- NCT01437241
- Lead Sponsor
- Hospitales Universitarios Virgen del Rocío
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Virological efficacy 52 weeks 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
Name Time Method Safety 52 weeks The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
Trial Locations
- Locations (11)
Hospital Universitario Puerto Real
🇪🇸Puerto Real, Cadiz, Spain
Hospital Universitario Reina Sofía
🇪🇸Cordoba, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Carlos Haya
🇪🇸Malaga, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital La Linea de la Concepción
🇪🇸La Linea de la Concepción, Cadiz, Spain
Hospital Costa del Sol
🇪🇸Marbella, Malaga, Spain
Hospital Ciudad de Jaén
🇪🇸Jaen, Spain