Status:
COMPLETED
FREE Study: Efficacy and Toxicity of Trizivir
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00405925
Start Date
March 1 2003
End Date
September 1 2009
Last Update
June 2 2010
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA