A Phase 3 interventional study of Kivexa in HIV Infections, sponsored by Germans Trias i Pujol Hospital. Completed at 20 sites in 2 countries. 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 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 period.
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 viral suppression in daily clinical practice.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 126 is above the median of 83 across 3,251 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 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD
Drug: Kivexa
Abacavir 600mg + lamivudine 300mg in ine tablet QD \* lopinavir/ritonavir 400/100 mg BID
Drug: Kivexa
abacavir 600mg + lamivudine 300mg in one tablet QD
To evaluate the virological response over the 48 weeks of the study.
Time frame: At 12, 24, 36 and 48 weeks
To evaluate the immunological efficacy (changes in 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 impact of treatment on the lipid profile.
Time frame: At 12, 24, 36 and 48 weeks
To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 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.
To analyse the mutations that appear in patients that present virological failure.
Time frame: When there is a virological failure.
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Germans Trias i Pujol Hospital