FREE Study: Efficacy and Toxicity of Trizivir

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00405925
First received: November 29, 2006
Last updated: May 31, 2010
Last verified: May 2010

November 29, 2006
May 31, 2010
March 2003
August 2009   (final data collection date for primary outcome measure)
Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).
Same as current
Complete list of historical versions of study NCT00405925 on ClinicalTrials.gov Archive Site
  • HIV-RNA <50 cop at week 96
  • HIV-RNA <400 and <50 cop/ml at week 48
  • Time to virological failure
  • Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts
  • Duration of change in CD4 cell count from baseline to >200,
  • Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio
  • Development of adverse events
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Trizivir
  • Drug: zidovudine,lamivudine,abacavir
    zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid
  • Active Comparator: combivir/kaletra
    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)
    Intervention: Drug: zidovudine,lamivudine,abacavir
  • Experimental: Trizivir
    patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra
    Intervention: Drug: Trizivir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00405925
LTC-184-010403
Not Provided
Not Provided
Rijnstate Hospital
GlaxoSmithKline
Principal Investigator: Clemens Richter, MD Rijnstate Hospital, Arnhem, the Netherlands
Study Director: P. Mulder Rijnstate Hospital, Arnhem, the Netherlands
Study Director: N. Langebeek Rijnstate Hospital, Arnhem, the Netherlands
Study Director: D. N. Burger Nijmegen, the Netherlands
Study Director: P. P. Koopmans Nijmegen, the Netherlands
Study Director: C. H. ten Napel Enschede, the Netherlands
Study Director: P. H. Groeneveld Isala kliniek, Zwolle, the Netherlands
Study Director: H. G. Sprenger Groningen, the Netherlands
Study Director: R. W. ten Kate Haarlem, the Netherlands
Study Director: M. E. van Kasteren Tilburg, the Netherlands
Study Director: J. D. Le grand Charleroi, Belgium
Study Director: R. Vriesendorp The Hague, the Netherlands
Study Director: B. Bravenboer Eindhoven, the Netherlands
Study Director: I. M. Hoepelman Utrecht, the Netherlands
Study Director: P. van Bentum Rijnstate Hospital, Arnhem, the Netherlands
Study Director: A. Smit-den Baars Rijnstate Hospital, Arnhem, the Netherlands
Rijnstate Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP