Overview

FREE Study: Efficacy and Toxicity of Trizivir

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
Antiretroviral naïve patients with <350 xE6/l CD4 cells and a HIV-viral load of > 30.000 cop/ml are started on combivir ® and Kaletra ®. When patients have reached an undetectable viral load of< 50 cop/ml on two consecutive occasions at least at week 12, but no later than week 24, they are randomised in either continuation with Combivir/Kaletra or switch to Trizivir ® twice daily one pill during 96 weeks. All patients randomised in the combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when they reach predefined switch criteria for elevated levels of fasting glucose or lipids.
Phase:
Phase 3
Details
Lead Sponsor:
Rijnstate Hospital
Collaborator:
GlaxoSmithKline
Treatments:
Abacavir
Lamivudine
Lamivudine, zidovudine drug combination
Zidovudine