drugset / Trial / NCT00528957
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
Timeline
- Start
- 2006-12-28
- Primary completion
- 2009-04-06
- Completion
- 2017-08-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Stavudine | Other / unclassified | 160 mg/m2 | — |
| Comparator | Stavudine | Other / unclassified | 300 mg | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 8 mg/kg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Comparator | Zidovudine | Small molecule | 1 mg/kg | — |
| Comparator | Zidovudine | Small molecule | 30 mg | — |