NCT00405925

FREE Study: Efficacy and Toxicity of Trizivir

Free Study: a Randomised, Open Label, Multicentre Strategic Study to Evaluate the Efficacy and Toxicity of an Early Switch From a PI-containing Regimen to Trizivir ® on Guidance of Viral Load in HIV-1 Infected , Antiretroviral naïve Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to compare the antiviral efficacy of an early switch from a boosted PI/2NRTI regimen to Trizivir (after undetectability of HIV-RNA has been achieved on 2 consecutive occasions) with uninterrupted use of the PI/2NRTI regimen for 96 weeks.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Trizivir
DRUG	zidovudine,lamivudine,abacavir	zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid

Timeline

• Start date: 2003-03-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2006-11-30
• Last updated: 2010-06-02

Locations

1 site across 1 country: Netherlands