FREE Study: Efficacy and Toxicity of Trizivir

Condition(s) targeted: HIV Infections

Intervention: Trizivir (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Rijnstate Hospital

Official(s) and/or principal investigator(s):
Clemens Richter, MD, Principal Investigator, Affiliation: Rijnstate Hospital, Arnhem, the Netherlands
P. Mulder, Study Director, Affiliation: Rijnstate Hospital, Arnhem, the Netherlands
N. Langebeek, Study Director, Affiliation: Rijnstate Hospital, Arnhem, the Netherlands
D. N. Burger, Study Director, Affiliation: Nijmegen, the Netherlands
P. P. Koopmans, Study Director, Affiliation: Nijmegen, the Netherlands
C. H. ten Napel, Study Director, Affiliation: Enschede, the Netherlands
P. H. Groeneveld, Study Director, Affiliation: Isala kliniek, Zwolle, the Netherlands
H. G. Sprenger, Study Director, Affiliation: Groningen, the Netherlands
R. W. ten Kate, Study Director, Affiliation: Haarlem, the Netherlands
M. E. van Kasteren, Study Director, Affiliation: Tilburg, the Netherlands
J. D. Le grand, Study Director, Affiliation: Charleroi, Belgium
R. Vriesendorp, Study Director, Affiliation: The Hague, the Netherlands
B. Bravenboer, Study Director, Affiliation: Eindhoven, the Netherlands
I. M. Hoepelman, Study Director, Affiliation: Utrecht, the Netherlands
P. van Bentum, Study Director, Affiliation: Rijnstate Hospital, Arnhem, the Netherlands
A. Smit-den Baars, Study Director, Affiliation: Rijnstate Hospital, Arnhem, the Netherlands

Overall contact:
Clemens Richter, MD, Phone: 0031(0)26-3786735, Email: CRichter@alysis.nl

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.

Official title: 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Clemens Richter, MD, Phone: 0031(0)26-3786735, Email: CRichter@alysis.nl

Rijnstate Hospital, Arnhem, Gelderland 6800 TA, Netherlands; Recruiting
Clemens Richter, MD, Phone: 0031(0)26-3786735, Email: CRichter@alysis.nl
C. Richter, MD, Principal Investigator
P. Mulder, Sub-Investigator
N. Langebeek, Sub-Investigator
P. van Bentum, Sub-Investigator
A. Smit-den Baars, Sub-Investigator

Starting date: March 2003
Ending date: December 2008
Last updated: March 28, 2008