Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
NCT ID: NCT00318123
Last Updated: 2008-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
126 participants
INTERVENTIONAL
2004-04-30
2007-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD
Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD
B
Abacavir 600mg + lamivudine 300mg in ine tablet QD \* lopinavir/ritonavir 400/100 mg BID
Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD
Interventions
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Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD
Eligibility Criteria
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Inclusion Criteria
2. HIV-1 infected patients.
3. Naive to antiretroviral treatment.
4. Candidate patient for initiating antiretroviral treatment\*.
5. Subject able to follow the treatment period.
6. Signature of the informed consent.
7. 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.
Exclusion Criteria
2. Pregnancy or breastfeeding.
3. Treatment for opportunistic infections or neoplasms associated with the stable HIV over the last 6 weeks.
4. Suspected or documented resistance to any of the investigational drugs.
5. Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
6. Subjects with abusive consumption of alcohol or illegal drugs.
7. Patients participating in another clinical trial.
8. Terminal renal disease.
18 Years
80 Years
ALL
No
Sponsors
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Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
OTHER
Germans Trias i Pujol Hospital
OTHER
Responsible Party
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Lluita Sida Foundation
Principal Investigators
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Bonaventura Clotet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
LLuita contra la Sida Foundation-HIV Unit
Locations
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Institute of Infections and Tropical Diseases University of Brescia
Brescia, , Italy
Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain
Hospital Generall de Alicante
Alicante, Alacant, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Granollers
Granollers, Barcelona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Virgen de las Nieves
Granada, Granada, Spain
Hopsital Gregorio Marañón
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hopsital Costa del Sol
Marbella, Malaga, Spain
Hospital Nuestra Sra del Rosell
Cartagena, Murcia, Spain
Hospital General de Murcia
Murcia, Murcia, Spain
Hospital Central de Asturias
Asturias, Oviedo, Spain
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain
Hospital Virgen Macarena
Seville, Sevilla, Spain
Hospital Virgen del Rocío
Seville, Sevilla, Spain
Hospital de Tarragona
Tarragona, Tarragona, Spain
Hospital Universitari Dr. Peset
Valencia, Valencia, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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2004-001282-18
Identifier Type: -
Identifier Source: secondary_id
LAKE
Identifier Type: -
Identifier Source: org_study_id
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