Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
NCT ID: NCT00314626
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
99 participants
INTERVENTIONAL
2004-11-30
2007-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
efavirenz
Efavirenz
Abacavir+lamivudine
Abacavir+lamivudine
B
efavirenz + 2 NUCS
No interventions assigned to this group
Interventions
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efavirenz
Efavirenz
Abacavir+lamivudine
Abacavir+lamivudine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HIV-1 infected patients.
3. Patients on HAART therapy including efavirenz and two NRTIs in a twice-daily regimen for 6 months at least.
4. Patients with an undetectable HIV-1 viral load over the last 6 months (at least 2 determinations separated by 3 months).
5. Subject able to follow the treatment period.
6. Signature of the informed consent.
7. 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.
Exclusion Criteria
2. Pregnancy or breastfeeding
3. Presence of opportunistic infections and/or recent tumours (\< 6 months).
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.
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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Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Hospital de la Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Virgen de las Nieves
Granada, Granada, Spain
Hospital de Aranzazu
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital San Millan de Logroño
Logroño, La Rioja, Spain
Hospital Arnau de Vilanova de Lleida
Lleida, Lleida, Spain
Hospital Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Severo Ochoa Leganés
Madrid, Madrid, Spain
Hospital de Móstoles
Móstoles, Madrid, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital Cristal-Piñor
Ourense, Ourense, Spain
Hospital Santa María Nai
Ourense, Ourense, Spain
Hospital de Navarra
Pamplona, Pamplona, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Hospital General de Valencia
Valencia, Valencia, Spain
Countries
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Other Identifiers
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2004-001198-25
Identifier Type: -
Identifier Source: secondary_id
ELA
Identifier Type: -
Identifier Source: org_study_id
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