FREE Study: Efficacy and Toxicity of Trizivir - Full Text View

Sponsor:	Rijnstate Hospital
Collaborator:	GlaxoSmithKline
Information provided by:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00405925

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Trizivir	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Trizivir

U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	320
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405925

Contacts

Contact: Clemens Richter, MD

0031(0)26-3786735

CRichter@alysis.nl

Locations

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

Sponsors and Collaborators

Rijnstate Hospital

GlaxoSmithKline

Investigators

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

More Information

No publications provided

Study ID Numbers:	LTC-184-010403
Study First Received:	November 29, 2006
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00405925 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:

AIDS
Treatment Naive

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010