Status:
COMPLETED
Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 antire...
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00314626
Start Date
November 1 2004
End Date
March 1 2007
Last Update
January 29 2008
Active Locations (16)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital de la Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
3
Hospital de Mataró
Mataró, Barcelona, Spain, 08304
4
Hospital Virgen de las Nieves
Granada, Granada, Spain, 18014