NCT00314626

Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily

Multicentre, Open Label, Prospective, Randomised Clinical Trial of an Antiretroviral Simplification Treatment With Efavirenz + Abacavir + 3TC Once Daily

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 antiretroviral simplification regimen.

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 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	efavirenz	Efavirenz
DRUG	Abacavir+lamivudine	Abacavir+lamivudine

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-02-01
• Completion: 2007-03-01
• First posted: 2006-04-14
• Last updated: 2008-01-29

Locations

16 sites across 1 country: Spain