Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy

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 OBR in the treatment of human immunodeficiency virus type 1 (HIV-1) infected antiretroviral treatment-experienced adolescents with plasma HIV-1 ribonucleic acid (RNA) levels greater than or equal to 1000 copies/mL.

Timeline

Start

2006-06

Primary completion

2008-09

Completion

2013-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Tenofovir DF vs Placebo; p = 0.55; Van Elteren test; note: No adjustments for multiple comparisons were made. NCT00352053 ↗

Drugs

Indications