drugset / Trial / NCT00405925
FREE Study: Efficacy and Toxicity of Trizivir
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2003-03
- Primary completion
- 2009-08
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abacavir | Other / unclassified | 300 mg | — |
| Comparator | Lamivudine | Other / unclassified | 150 mg | — |
| Subject | Trizivir | Unknown | — | — |
| Comparator | Zidovudine | Small molecule | 300 mg | — |