Trial | NCT00405925  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    207
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.
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.
Study Started
Mar 31
2003
Primary Completion
Aug 31
2009
Study Completion
Sep 30
2009
Last Update
Jun 02
2010
Estimate

Drug Trizivir

Drug zidovudine,lamivudine,abacavir

zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid

combivir/kaletra Active Comparator

All patients started with combivir/Kaletra and were randomized if they reached undetectable viral load (2 times) within 24 weeks into continuation of the same regimen or Trizivir (2 arms)

Trizivir Experimental

patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra

Criteria 

Inclusion Criteria:

Adults >18 years of age, confirmed HIV-1 infection, never received antiretrovirals before, plasma-HIV-RNA >30.000 cop/ml, CD4 < 350 E6/l.

Exclusion Criteria:

pregnancy, women using proven barrier methods of contraception, defined uncontrolled active AIDS defining complication, being on treatment for diabetes, other serious illnesses, expected non-compliance, defined laboratory abnormalities
No Results Posted