Status:
COMPLETED
Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients
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 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 per...
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 vir...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00318123
Start Date
April 1 2004
End Date
April 1 2007
Last Update
January 29 2008
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Infections and Tropical Diseases University of Brescia
Brescia, Italy, 25125
2
Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain, 15405
3
Hospital Generall de Alicante
Alicante, Alacant, Spain, 03010
4
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916