drugset / Trial / NCT00528957

Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

NCT00528957

Phase 3 Completed 97 enrolled Gilead Sciences
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

EvaluationDrugModalityDoseRoute
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