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.
Name: Tenofovir DF
Description: Tenofovir DF 300-mg tablet, administered orally, daily + OBRType: DrugOBR + Tenofovir DF
Name: Placebo
Description: Tenofovir DF Placebo administered orally, daily + OBRType: DrugOBR + Tenofovir DF Placebo
Description: 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).
Measure: Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA Time: Baseline to 24 WeeksDescription: 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).
Measure: Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA Time: Baseline to 48 weeksDescription: No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measure: Change From Baseline to Week 336 in HIV-1 RNA Time: Baseline to 336 weeksDescription: No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measure: Change From Baseline to Week 336 in CD4 Count Time: Baseline to 336 weeksDescription: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measure: Change From Baseline to Week 24 in CD4 Percentage Time: Baseline to 24 weeksDescription: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measure: Change From Baseline to Week 48 in CD4 Percentage Time: Baseline to 48 weeksDescription: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measure: Change From Baseline to Week 96 in CD4 Percentage Time: Baseline to 96 weeksDescription: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measure: Change From Baseline to Week 144 in CD4 Percentage Time: Baseline to 144 weeksDescription: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measure: Change From Baseline to Week 192 in CD4 Percentage Time: Baseline to 192 weeksDescription: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measure: Change From Baseline to Week 240 in CD4 Percentage Time: Baseline to 240 weeksDescription: CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Measure: Change From Baseline to Week 288 in CD4 Percentage Time: Baseline to 288 weeksDescription: No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measure: Change From Baseline to Week 336 in CD4 Percentage Time: Baseline to 336 weeksDescription: No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336 Time: Baseline to 336 weeksDescription: No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336 Time: Week 336Description: No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336 Time: Week 336Description: 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.
Measure: Percentage of Participants With Virologic Failure Through Week 48 Time: Up to 48 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
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.. 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 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 HIV Infections HIV Infections This is a 48-week, randomized, double-blind, placebo-controlled, multicenter study of the safety and efficacy of tenofovir DF as part of an optimized antiretroviral regimen in HIV-1 infected adolescents (12 years to < 18 years of age) who are failing their current antiretroviral regimen and have HIV-1 RNA levels ≥ 1000 copies/mL at screening. --- K65R ---
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.. 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 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 HIV Infections HIV Infections This is a 48-week, randomized, double-blind, placebo-controlled, multicenter study of the safety and efficacy of tenofovir DF as part of an optimized antiretroviral regimen in HIV-1 infected adolescents (12 years to < 18 years of age) who are failing their current antiretroviral regimen and have HIV-1 RNA levels ≥ 1000 copies/mL at screening. --- K65R --- --- K65R ---