Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
- Registration Number
- NCT00314626
- Lead Sponsor
- Germans Trias i Pujol Hospital
- Brief Summary
To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.
- Detailed Description
Treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the HIV infection.
The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 NRTI taken twice daily.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- Age > 18 years.
- HIV-1 infected patients.
- Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
- Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
- Subject able to follow the treatment period.
- Signature of the informed consent.
- Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
- Hepatic tests > 5 times above normality.
- Pregnancy or breastfeeding
- Presence of opportunistic infections and/or recent tumours (< 6 months).
- Suspected or documented resistance to any of the investigational drugs.
- Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
- Subjects with abusive consumption of alcohol or illegal drugs.
- Patients participating in another clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Abacavir+lamivudine abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h A efavirenz abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
- Primary Outcome Measures
Name Time Method Viral load of HIV-1 at each visit with regard to the baseline visit. At 12, 24, 36 and 48 weeks
- Secondary Outcome Measures
Name Time Method To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period. At 12, 24, 36 and 48 weeks To evaluate the tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 48-week treatment period. At 12, 24, 36 and 48 weeks To evaluate treatment adherence (assessed by a self-reported questionnaire and with graduated satisfaction scales) and patient quality of life (assessed by means of the MOS-HIV questionnaire). At 12, 24, 36 and 48 weeks
Trial Locations
- Locations (16)
Germans Trias i Pujol Hospital
🇪🇸Badalona, Barcelona, Spain
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain
Hospital de Mataró
🇪🇸Mataro, Barcelona, Spain
Hospital San Millan de Logroño
🇪🇸Logroño, La Rioja, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Santa Cruz de Tenerife, Spain
Hospital Arnau de Vilanova de Lleida
🇪🇸Lleida, Spain
Hospital Cristal-Piñor
🇪🇸Ourense, Spain
Hospital de la Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Móstoles
🇪🇸Mostoles, Madrid, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital de Aranzazu
🇪🇸San Sebastian, Guipuzcoa, Spain
Hospital Principe de Asturias
🇪🇸Alcala de Henares, Madrid, Spain
Hospital Severo Ochoa Leganés
🇪🇸Madrid, Spain
Hospital Santa MarÃa Nai
🇪🇸Ourense, Spain
Hospital de Navarra
🇪🇸Pamplona, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain