Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
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
1 other identifier
interventional
87
2 countries
18
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv-infections
Started Jun 2006
Longer than P75 for phase_3 hiv-infections
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 13, 2006
CompletedFirst Posted
Study publicly available on registry
July 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedResults Posted
Study results publicly available
August 19, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 14, 2015
June 1, 2015
2.3 years
July 13, 2006
March 5, 2010
June 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA
DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value. Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed).
Baseline to 24 Weeks
Secondary Outcomes (50)
Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA
Baseline to 48 weeks
Change From Baseline to Week 24 in HIV-1 RNA
Baseline to 24 weeks
Change From Baseline to Week 48 in HIV-1 RNA
Baseline to 48 weeks
Change From Baseline to Week 96 in HIV-1 RNA
Baseline to 96 weeks
Change From Baseline to Week 144 in HIV-1 RNA
Baseline to 144 weeks
- +45 more secondary outcomes
Study Arms (2)
OBR + Tenofovir DF
EXPERIMENTALTenofovir DF administered orally, one tablet daily without regard to meals
OBR + Tenofovir DF Placebo
PLACEBO COMPARATORPlacebo to match tenofovir DF administered orally, one tablet daily without regard to meals
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients requiring didanosine in background regimen
- Prior history of significant renal disease
- Prior history of significant bone disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (18)
Faculdade de Medicina - UFMG
Belo Horizonte - MG, Brazil
Santa Casa de Belo Horizonte
Belo Horizonte - MG, Brazil
Hospital e Maternidade Celso Pierro
Campinas - SP, Brazil
Universidade Estadual de Campinas - UNICAMP
Campinas - SP, Brazil
Centro de Doenças Infecciosas e Parasitárias
Campo Grande - MS, Brazil
Hospital das Clinicas da Universidade Federal do Parana - UFPR
Curitiba - PR, Brazil
Hospital Infantil Joana de Gusmão
Florianópolis - SC, Brazil
Hospital Municipal Sao Jose
Joinville - SC, Brazil
Hospital Materno Infantil Professor Fernando Figueira- IMIP
Recife, Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, Brazil
Hospital Geral de Nova Iguacu Ambulatorio de DST e AIDS
Rio de Jeneiro, Brazil
Hospital Guilherme Alvaro
Santos, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP Depto de Pediatria
Sao Paulo - SP, Brazil
Instituto de Infectologia Emilio Ribas
Sao Paulo - SP, Brazil
NEIMPE - Dept of Pediatrics Hospital das Clinicas FMRP-USP
São Paulo, Brazil
Universidade Federal de Sao Paulo
Vila Clementino, Brazil
Hospital Infantil Nossa Senhora da Gloria Servico de Infectologia Pediatria
Vitoria - ES, Brazil
Hospital del Nino
Panama City, Panama
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Participants left the study for a number of reasons (eg, turned 18 years old, switched to a different HIV treatment regimen), which led to small numbers of participants analyzed at later time points, and the study was concluded earlier than planned.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Erin Quirk, MD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2006
First Posted
July 14, 2006
Study Start
June 1, 2006
Primary Completion
September 1, 2008
Study Completion
December 1, 2013
Last Updated
July 14, 2015
Results First Posted
August 19, 2010
Record last verified: 2015-06