FREE Study: Efficacy and Toxicity of Trizivir
- Conditions
- HIV Infections
- Interventions
- Drug: zidovudine,lamivudine,abacavir
- Registration Number
- NCT00405925
- Lead Sponsor
- Rijnstate Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- Adults >18 years of age, confirmed HIV-1 infection, never received antiretrovirals before, plasma-HIV-RNA >30.000 cop/ml, CD4 < 350 E6/l.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trizivir Trizivir patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra combivir/kaletra zidovudine,lamivudine,abacavir 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)
- Primary Outcome Measures
Name Time Method Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).
- Secondary Outcome Measures
Name Time Method Duration of change in CD4 cell count from baseline to >200, Time to virological failure Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio Development of adverse events HIV-RNA <50 cop at week 96 HIV-RNA <400 and <50 cop/ml at week 48 Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts
Trial Locations
- Locations (1)
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands