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FREE Study: Efficacy and Toxicity of Trizivir

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

Trizivir

zidovudine,lamivudine,abacavir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring AIDS, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

combivir/kaletra

Trizivir

Arm Description

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)

patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra

Outcomes

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

Full Information

NCT ID

NCT00405925

First Posted

November 29, 2006

Last Updated

May 31, 2010

Sponsor

Rijnstate Hospital

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00405925

Brief Title

FREE Study: Efficacy and Toxicity of Trizivir

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 Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rijnstate Hospital

Collaborators

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

AIDS, Treatment Naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

combivir/kaletra

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Trizivir

Arm Type

Experimental

Arm Description

patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra

Intervention Type

Drug

Intervention Name(s)

Trizivir

Intervention Type

Drug

Intervention Name(s)

zidovudine,lamivudine,abacavir

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

HIV-RNA <50 cop at week 96

Title

HIV-RNA <400 and <50 cop/ml at week 48

Title

Time to virological failure

Title

Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts

Title

Duration of change in CD4 cell count from baseline to >200,

Title

Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio

Title

Development of adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: