A Phase 3 interventional study of efavirenz and Abacavir+lamivudine in HIV Infections, sponsored by Germans Trias i Pujol Hospital. Completed at 16 sites in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-01-29.
Sponsored by Germans Trias i Pujol Hospital · Phase 3, Interventional, and Treatment
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 antiretroviral simplification regimen.
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 maintain controlled viral load for longer, delaying the evolution of the HIV infection.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 99 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Germans Trias i Pujol Hospital is the lead sponsor of 87 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h
Drug: efavirenz · Drug: Abacavir+lamivudine
efavirenz + 2 NUCS
Efavirenz
Also known as: sustiva
Abacavir+lamivudine
Also known as: Kivexa
Viral load of HIV-1 at each visit with regard to the baseline visit.
Time frame: At 12, 24, 36 and 48 weeks
To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period.
Time frame: At 12, 24, 36 and 48 weeks
To evaluate the tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 48-week treatment period.
Time frame: 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).
Time frame: At 12, 24, 36 and 48 weeks
This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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Germans Trias i Pujol Hospital