FREE Study: Efficacy and Toxicity of Trizivir

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405925
• Other study ID #: LTC-184-010403
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2006
• Last updated: May 31, 2010
• Start date: March 2003
• Est. completion date: September 2009

Study information

• Verified date: May 2010
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Trizivir

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

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).
Secondary	HIV-RNA <50 cop at week 96
Secondary	HIV-RNA <400 and <50 cop/ml at week 48
Secondary	Time to virological failure
Secondary	Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts
Secondary	Duration of change in CD4 cell count from baseline to >200,
Secondary	Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio
Secondary	Development of adverse events