Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
- Registration Number
- NCT00318123
- Lead Sponsor
- Germans Trias i Pujol Hospital
- Brief Summary
To evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.
- Detailed Description
The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in several clinical trials. Even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice.
Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication.
It has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves.
The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- Age> 18 years.
- HIV-1 infected patients.
- Naive to antiretroviral treatment.
- Candidate patient for initiating antiretroviral treatment*.
- Subject able to follow the treatment period.
- Signature of the informed consent.
- Women may not be fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use two contraceptive methods during the study, one of them at least being a barrier method.
- Hepatic tests > 5 times above normality.
- Pregnancy or breastfeeding.
- Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
- 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.
- Terminal renal disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Kivexa Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD B Kivexa Abacavir 600mg + lamivudine 300mg in ine tablet QD \* lopinavir/ritonavir 400/100 mg BID
- Primary Outcome Measures
Name Time Method To evaluate the virological response over the 48 weeks of the study. At 12, 24, 36 and 48 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the immunological efficacy (changes in CD4 and CD8 counts) of the combination studied over the follow-up period. At 12, 24, 36 and 48 weeks. To evaluate the impact of treatment on the lipid profile. At 12, 24, 36 and 48 weeks To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 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. To analyse the mutations that appear in patients that present virological failure. When there is a virological failure.
Trial Locations
- Locations (20)
Hospital Central de Asturias
🇪🇸Asturias, Oviedo, Spain
Hopsital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Institute of Infections and Tropical Diseases University of Brescia
🇮🇹Brescia, Italy
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Generall de Alicante
🇪🇸Alicante, Alacant, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hopsital Costa del Sol
🇪🇸Marbella, Malaga, Spain
Hospital General de Murcia
🇪🇸Murcia, Spain
Hospital de Tarragona
🇪🇸Tarragona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Canarias, Spain
Hospital ClÃnico Universitario de Santiago
🇪🇸Santiago de Compostela, Galicia, Spain
Hospital Virgen del RocÃo
🇪🇸Sevilla, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Universitari Dr. Peset
🇪🇸Valencia, Spain
Hospital Nuestra Sra del Rosell
🇪🇸Cartagena, Murcia, Spain
Hospital Arquitecto Marcide
🇪🇸Ferrol, A Coruña, Spain
Hospital de Granollers
🇪🇸Granollers, Barcelona, Spain
Hospital Xeral de Vigo
🇪🇸Vigo, Pontevedra, Spain