NCT00318123

Study to Evaluate the Effectiveness of ABC+3TC +EFV in Once-Daily Regimens Versus KLT in Twice-Daily Regimens in Naive HIV Patients

Multicentre, Open Label, Prospective, Randomised Clinical Trial to Evaluate the Effectiveness of Abacavir 600 mg+ Lamivudine 300 mg as QD+ Efavirenz 600 mg QD Versus Kaletra 400/100 mg BID as Initial Antiretroviral Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 period.

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 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Kivexa	abacavir 600mg + lamivudine 300mg in one tablet QD

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-04-26
• Last updated: 2008-01-29

Locations

20 sites across 2 countries: Italy, Spain