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Report for Clinical Trial NCT00352053

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT00352053 HIV Infections
MeSH:HIV Infections

2 Interventions

Name: Tenofovir DF

Description: Tenofovir DF 300-mg tablet, administered orally, daily + OBR
Type: Drug
Group Labels: 1

OBR + Tenofovir DF

Name: Placebo

Description: Tenofovir DF Placebo administered orally, daily + OBR
Type: Drug
Group Labels: 1

OBR + Tenofovir DF Placebo


Primary Outcomes

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 Weeks

Secondary Outcomes

Description: 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 weeks

Measure: Change From Baseline to Week 24 in HIV-1 RNA

Time: Baseline to 24 weeks

Measure: Change From Baseline to Week 48 in HIV-1 RNA

Time: Baseline to 48 weeks

Measure: Change From Baseline to Week 96 in HIV-1 RNA

Time: Baseline to 96 weeks

Measure: Change From Baseline to Week 144 in HIV-1 RNA

Time: Baseline to 144 weeks

Measure: Change From Baseline to Week 192 in HIV-1 RNA

Time: Baseline to 192 weeks

Measure: Change From Baseline to Week 240 in HIV-1 RNA

Time: Baseline to 240 weeks

Measure: Change From Baseline to Week 288 in HIV-1 RNA

Time: Baseline to 288 weeks

Description: 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 weeks

Measure: Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count

Time: Baseline to 24 weeks

Measure: Change From Baseline to Week 48 in CD4 Count

Time: Baseline to 48 weeks

Measure: Change From Baseline to Week 96 in CD4 Count

Time: Baseline to 96 weeks

Measure: Change From Baseline to Week 144 in CD4 Count

Time: Baseline to 144 weeks

Measure: Change From Baseline to Week 192 in CD4 Count

Time: Baseline to 192 weeks

Measure: Change From Baseline to Week 240 in CD4 Count

Time: Baseline to 240 weeks

Measure: Change From Baseline to Week 288 in CD4 Count

Time: Baseline to 288 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24

Time: Baseline to 24 weeks

Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48

Time: Baseline to 48 weeks

Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96

Time: Baseline to 96 weeks

Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144

Time: Baseline to 144 weeks

Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192

Time: Baseline to 192 weeks

Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240

Time: Baseline to 240 weeks

Measure: Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288

Time: Baseline to 288 weeks

Description: 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 weeks

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24

Time: Week 24

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

Time: Week 48

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

Time: Week 96

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144

Time: Week 144

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192

Time: Week 192

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240

Time: Week 240

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288

Time: Week 288

Description: 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 336

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

Time: Week 24

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

Time: Week 48

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

Time: Week 96

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144

Time: Week 144

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192

Time: Week 192

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240

Time: Week 240

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288

Time: Week 288

Description: 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 336

Description: 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 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes