HIV Infections
Conditions
Keywords
AIDS, Treatment Naive
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.
Interventions
DRUGTrizivir
DRUGzidovudine,lamivudine,abacavir
zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid
Sponsors
GlaxoSmithKline
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| HIV-RNA <50 cop at week 96 | — |
| Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio | — |
| Development of adverse events | — |
| Duration of change in CD4 cell count from baseline to >200, | — |
Countries
Netherlands
Outcome results
None listed