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 Drug: zidovudine,lamivudine,abacavir	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Lamivudine Abacavir Combivir Abacavir succinate Abacavir sulfate 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

Enrollment:	207
Study Start Date:	March 2003
Study Completion Date:	September 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)	Drug: zidovudine,lamivudine,abacavir zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid
Experimental: Trizivir patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra	Drug: Trizivir

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

Locations

Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA

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

ClinicalTrials.gov Identifier:	NCT00405925 History of Changes
Other Study ID Numbers:	LTC-184-010403
Study First Received:	November 29, 2006
Last Updated:	May 31, 2010
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:

AIDS
Treatment Naive

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Lamivudine

Abacavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012