At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 87 enrolled

Drug / intervention

Tenofovir DF +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00352053

NCT00352053Phase 3Completed

Compare CT.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Tenofovir DF as Part of an Optimized Antiretroviral Regimen in HIV-1-Infected Adolescents

Gilead Sciences·interventional·Posted Jul 14, 2006·Updated Jul 14, 2015

In Brief

A Phase 3 clinical trial evaluating Tenofovir DF and Placebo for HIV Infections. Completed, enrolled 87 participants across 18 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV Infections

CountriesBrazil, Panama

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2006

First PostedJul 2006

Primary CompletionSep 2008

Study CompletionDec 2013

TodayJul 2026

First PostedJul 14, 2006

Enrollment StartJun 1, 2006

Primary CompletionSep 1, 2008

Study CompletionDec 1, 2013

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 20.0 years ago

Interventions

Tenofovir DFdrug

Tenofovir DF 300-mg tablet, administered orally, daily + OBR

Placebodrug

Tenofovir DF Placebo administered orally, daily + OBR