FREE Study: Efficacy and Toxicity of Trizivir

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.

Conditions

• HIV Infections

Interventions

DRUG

Trizivir

DRUG

zidovudine,lamivudine,abacavir

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

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Rijnstate Hospital

  lead OTHER

Principal Investigators

• Clemens Richter, MD · Rijnstate Hospital, Arnhem, the Netherlands

• P. Mulder · Rijnstate Hospital, Arnhem, the Netherlands

• N. Langebeek · Rijnstate Hospital, Arnhem, the Netherlands

• D. N. Burger · Nijmegen, the Netherlands

• P. P. Koopmans · Nijmegen, the Netherlands

• C. H. ten Napel · Enschede, the Netherlands

• P. H. Groeneveld · Isala kliniek, Zwolle, the Netherlands

• H. G. Sprenger · Groningen, the Netherlands

• R. W. ten Kate · Haarlem, the Netherlands

• M. E. van Kasteren · Tilburg, the Netherlands

• J. D. Le grand · Charleroi, Belgium

• R. Vriesendorp · The Hague, the Netherlands

• B. Bravenboer · Eindhoven, the Netherlands

• I. M. Hoepelman · Utrecht, the Netherlands

• P. van Bentum · Rijnstate Hospital, Arnhem, the Netherlands

• A. Smit-den Baars · Rijnstate Hospital, Arnhem, the Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-03-31

Primary Completion

2009-08-31

Completion

2009-09-30

Countries

• Netherlands

Study Locations