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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

Major Inclusion Criteria:

• 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 Criteria:

• Patients requiring didanosine in background regimen

• Prior history of significant renal disease

• Prior history of significant bone disease