HIV Infections Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | December 2013 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | 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 | NEIMPE - Dept of Pediatrics Hospital das Clinicas FMRP-USP | Sao Paulo | |
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 | Universidade Federal de Sao Paulo | Vila Clementino | |
Brazil | Hospital Infantil Nossa Senhora da Gloria Servico de Infectologia Pediatria | Vitoria - ES | |
Panama | Hospital del Nino | Panama City |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
Brazil, Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA | DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value. Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed). |
Baseline to 48 weeks | No |
Secondary | Change From Baseline to Week 24 in HIV-1 RNA | Baseline to 24 weeks | No | |
Secondary | Change From Baseline to Week 48 in HIV-1 RNA | Baseline to 48 weeks | No | |
Secondary | Change From Baseline to Week 96 in HIV-1 RNA | Baseline to 96 weeks | No | |
Secondary | Change From Baseline to Week 144 in HIV-1 RNA | Baseline to 144 weeks | No | |
Secondary | Change From Baseline to Week 192 in HIV-1 RNA | Baseline to 192 weeks | No | |
Secondary | Change From Baseline to Week 240 in HIV-1 RNA | Baseline to 240 weeks | No | |
Secondary | Change From Baseline to Week 288 in HIV-1 RNA | Baseline to 288 weeks | No | |
Secondary | Change From Baseline to Week 336 in HIV-1 RNA | No analysis was performed because the last study participant discontinued after Week 294 and the study was closed. | Baseline to 336 weeks | No |
Secondary | Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count | Baseline to 24 weeks | No | |
Secondary | Change From Baseline to Week 48 in CD4 Count | Baseline to 48 weeks | No | |
Secondary | Change From Baseline to Week 96 in CD4 Count | Baseline to 96 weeks | No | |
Secondary | Change From Baseline to Week 144 in CD4 Count | Baseline to 144 weeks | No | |
Secondary | Change From Baseline to Week 192 in CD4 Count | Baseline to 192 weeks | No | |
Secondary | Change From Baseline to Week 240 in CD4 Count | Baseline to 240 weeks | No | |
Secondary | Change From Baseline to Week 288 in CD4 Count | Baseline to 288 weeks | No | |
Secondary | Change From Baseline to Week 336 in CD4 Count | No analysis was performed because the last study participant discontinued after Week 294 and the study was closed. | Baseline to 336 weeks | No |
Secondary | Change From Baseline to Week 24 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | Baseline to 24 weeks | No |
Secondary | Change From Baseline to Week 48 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | Baseline to 48 weeks | No |
Secondary | Change From Baseline to Week 96 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | Baseline to 96 weeks | No |
Secondary | Change From Baseline to Week 144 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | Baseline to 144 weeks | No |
Secondary | Change From Baseline to Week 192 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | Baseline to 192 weeks | No |
Secondary | Change From Baseline to Week 240 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | Baseline to 240 weeks | No |
Secondary | Change From Baseline to Week 288 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | Baseline to 288 weeks | No |
Secondary | Change From Baseline to Week 336 in CD4 Percentage | No analysis was performed because the last study participant discontinued after Week 294 and the study was closed. | Baseline to 336 weeks | No |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0 log10 Copies/mL From Baseline to Week 24 | Baseline to 24 weeks | No | |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0 log10 Copies/mL From Baseline to Week 48 | Baseline to 48 weeks | No | |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0 log10 Copies/mL From Baseline to Week 96 | Baseline to 96 weeks | No | |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0 log10 Copies/mL From Baseline to Week 144 | Baseline to 144 weeks | No | |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0 log10 Copies/mL From Baseline to Week 192 | Baseline to 192 weeks | No | |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0 log10 Copies/mL From Baseline to Week 240 | Baseline to 240 weeks | No | |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0log 10 Copies/mL From Baseline to Week 288 | Baseline to 288 weeks | No | |
Secondary | Percentage of Participants With an HIV-1 RNA Decrease of = 1.0 log10 Copies/mL From Baseline to Week 336 | No analysis was performed because the last study participant discontinued after Week 294 and the study was closed. | Baseline to 336 weeks | No |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24 | Week 24 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | Week 48 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | Week 96 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | Week 144 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192 | Week 192 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240 | Week 240 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288 | Week 288 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336 | No analysis was performed because the last study participant discontinued after Week 294 and the study was closed. | Week 336 | No |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 | Week 24 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | Week 48 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | Week 96 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 | Week 144 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 | Week 192 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240 | Week 240 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288 | Week 288 | No | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336 | No analysis was performed because the last study participant discontinued after Week 294 and the study was closed. | Week 336 | No |
Secondary | Percentage of Participants With Virologic Failure Through Week 48 | Virologic failure was defined as either nonresponse or viral rebound. Nonresponse (failure to achieve response). Response was defined as either A = 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or HIV-1 RNA < 400 copies/mL at 2 consecutive visits. Viral rebound was defined as either Participants who achieved a = 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values = 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values = the baseline value at 2 consecutive visits, or Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits. The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase. |
Up to 48 weeks | No |
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