Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
Multicentre, Open Label, Prospective, Randomised Clinical Trial to Evaluate the Effectiveness of Abacavir 600 mg+ Lamivudine 300 mg as QD+ Efavirenz 600 mg QD Versus Kaletra 400/100 mg BID as Initial Antiretroviral Treatment
2 other identifiers
interventional
126
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv-infections
Started Apr 2004
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 25, 2006
CompletedFirst Posted
Study publicly available on registry
April 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 29, 2008
January 1, 2008
3 years
April 25, 2006
January 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the virological response over the 48 weeks of the study.
At 12, 24, 36 and 48 weeks
Secondary Outcomes (5)
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.
Study Arms (2)
A
EXPERIMENTALAbacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD
B
EXPERIMENTALAbacavir 600mg + lamivudine 300mg in ine tablet QD \* lopinavir/ritonavir 400/100 mg BID
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Institute of Infections and Tropical Diseases University of Brescia
Brescia, 25125, Italy
Hospital Arquitecto Marcide
Ferrol, A Coruña, 15405, Spain
Hospital Generall de Alicante
Alicante, Alacant, 03010, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital de Granollers
Granollers, Barcelona, 08400, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, 15706, Spain
Hospital Virgen de las Nieves
Granada, Granada, 18014, Spain
Hopsital Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hopsital Costa del Sol
Marbella, Malaga, 29600, Spain
Hospital Nuestra Sra del Rosell
Cartagena, Murcia, 30203, Spain
Hospital General de Murcia
Murcia, Murcia, 30003, Spain
Hospital Central de Asturias
Asturias, Oviedo, 33006, Spain
Hospital Xeral de Vigo
Vigo, Pontevedra, 36204, Spain
Hospital Virgen Macarena
Seville, Sevilla, 41009, Spain
Hospital Virgen del Rocío
Seville, Sevilla, 41013, Spain
Hospital de Tarragona
Tarragona, Tarragona, 43007, Spain
Hospital Universitari Dr. Peset
Valencia, Valencia, 46017, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonaventura Clotet, MD, PhD
LLuita contra la Sida Foundation-HIV Unit
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 25, 2006
First Posted
April 26, 2006
Study Start
April 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
January 29, 2008
Record last verified: 2008-01