Status:
COMPLETED
Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
Lead Sponsor:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) plus a genotype-guided optimized background regimen (OBR) compared to placebo plus O...
Detailed Description
This is a 48-week, randomized, double-blind, placebo-controlled, multicenter study of the safety and efficacy of tenofovir DF as part of an optimized antiretroviral regimen in HIV-1 infected adolescen...
Eligibility Criteria
Inclusion
- Major
- Weight ≥ 35 kg
- Documented laboratory diagnosis of HIV infection
- Plasma HIV-1 RNA ≥ 1000 copies/mL
- Prior antiretroviral treatment experience with at least 2 antiretroviral drug classes
- Naive to tenofovir DF
- Absence of K65R mutation on genotypic testing
Exclusion
- Patients requiring didanosine in background regimen
- Prior history of significant renal disease
- Prior history of significant bone disease
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00352053
Start Date
June 1 2006
End Date
December 1 2013
Last Update
July 14 2015
Active Locations (18)
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1
Faculdade de Medicina - UFMG
Belo Horizonte - MG, Brazil
2
Santa Casa de Belo Horizonte
Belo Horizonte - MG, Brazil
3
Hospital e Maternidade Celso Pierro
Campinas - SP, Brazil
4
Universidade Estadual de Campinas - UNICAMP
Campinas - SP, Brazil