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

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

Outcome

Missed primary endpoint

paper Our study did not demonstrate noninferiority of TDF versus d4T or ZDV at Week 48. PMID 25760565 ↗

Publications

Saez-Llorens X, Castano E, Rathore M, Church J, Deville J, Gaur A, Estripeaut D, White K, Arterburn S, Enejosa JV, Cheng AK, Chuck SL, Rhee MS. A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. Pediatr Infect Dis J. 2015 Apr;34(4):376-82. doi: 10.1097/INF.0000000000000289.

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	—