FREE Study: Efficacy and Toxicity of Trizivir

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Trizivir
* Drug: zidovudine,lamivudine,abacavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: combivir/kaletra<br>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<br>* zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid<br>|
| Experimental: Trizivir<br>patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra | Drug: Trizivir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS, Treatment Naive