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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combivir/kaletra | Active Comparator | 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) |
|
| Trizivir | Experimental | patients who reach undetectable HIV-RNA within 24 weeks are randomized to switch to trizivir or continuation of combivir/kaletra |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trizivir | Drug |
| ||
| zidovudine,lamivudine,abacavir |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Richter, MD | Rijnstate Hospital, Arnhem, the Netherlands | Principal Investigator |
| P. Mulder | Rijnstate Hospital, Arnhem, the Netherlands | Study Director |
| N. Langebeek | Rijnstate Hospital, Arnhem, the Netherlands | Study Director |
| D. N. Burger | Nijmegen, the Netherlands | Study Director |
| P. P. Koopmans | Nijmegen, the Netherlands | Study Director |
| C. H. ten Napel | Enschede, the Netherlands | Study Director |
| P. H. Groeneveld | Isala kliniek, Zwolle, the Netherlands | Study Director |
| H. G. Sprenger | Groningen, the Netherlands | Study Director |
| R. W. ten Kate | Haarlem, the Netherlands | Study Director |
| M. E. van Kasteren |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6800 TA | Netherlands |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C418262 | abacavir, lamivudine, and zidovudine drug combination |
| D015215 | Zidovudine |
| C492871 | abacavir, lamivudine drug combination |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid |
|
| 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 |
| Tilburg, the Netherlands |
| Study Director |
| J. D. Le grand | Charleroi, Belgium | Study Director |
| R. Vriesendorp | The Hague, the Netherlands | Study Director |
| B. Bravenboer | Eindhoven, the Netherlands | Study Director |
| I. M. Hoepelman | Utrecht, the Netherlands | Study Director |
| P. van Bentum | Rijnstate Hospital, Arnhem, the Netherlands | Study Director |
| A. Smit-den Baars | Rijnstate Hospital, Arnhem, the Netherlands | Study Director |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D006571 |
| Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |