Clinical trial NCT00405925: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: AIDS
Treatment Naive
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-11-30
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).
Secondary outcomes:
measure: HIV-RNA <50 cop at week 96
measure: HIV-RNA <400 and <50 cop/ml at week 48
measure: Time to virological failure
measure: Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts
measure: Duration of change in CD4 cell count from baseline to >200,
measure: Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio
measure: Development of adverse events
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital, Arnhem, the Netherlands
name: Clemens Richter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rijnstate Hospital, Arnhem, the Netherlands
name: P. Mulder
role: STUDY_DIRECTOR
affiliation: Rijnstate Hospital, Arnhem, the Netherlands
name: N. Langebeek
role: STUDY_DIRECTOR
affiliation: Nijmegen, the Netherlands
name: D. N. Burger
role: STUDY_DIRECTOR
affiliation: Nijmegen, the Netherlands
name: P. P. Koopmans
role: STUDY_DIRECTOR
affiliation: Enschede, the Netherlands
name: C. H. ten Napel
role: STUDY_DIRECTOR
affiliation: Isala kliniek, Zwolle, the Netherlands
name: P. H. Groeneveld
role: STUDY_DIRECTOR
affiliation: Groningen, the Netherlands
name: H. G. Sprenger
role: STUDY_DIRECTOR
affiliation: Haarlem, the Netherlands
name: R. W. ten Kate
role: STUDY_DIRECTOR
affiliation: Tilburg, the Netherlands
name: M. E. van Kasteren
role: STUDY_DIRECTOR
affiliation: Charleroi, Belgium
name: J. D. Le grand
role: STUDY_DIRECTOR
affiliation: The Hague, the Netherlands
name: R. Vriesendorp
role: STUDY_DIRECTOR
affiliation: Eindhoven, the Netherlands
name: B. Bravenboer
role: STUDY_DIRECTOR
affiliation: Utrecht, the Netherlands
name: I. M. Hoepelman
role: STUDY_DIRECTOR
affiliation: Rijnstate Hospital, Arnhem, the Netherlands
name: P. van Bentum
role: STUDY_DIRECTOR
affiliation: Rijnstate Hospital, Arnhem, the Netherlands
name: A. Smit-den Baars
role: STUDY_DIRECTOR
References: