Phase 3
Completed N=87
Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
Source: ClinicalTrials.gov NCT00352053 ↗Enrolled (actual)
87
Serious AEs
19.6%
Results posted
Aug 2010
Primary outcomePrimary: Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA — -1.580; -1.549 log10 copies/mL — p=0.55
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA |
-1.580; -1.549 | 0.55 |
| SECONDARY Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA |
-1.423; -1.352 | 0.40 |
| SECONDARY Change From Baseline to Week 24 in HIV-1 RNA |
-1.23; -1.27; 0.0; -0.1 | 0.58 |
| SECONDARY Change From Baseline to Week 48 in HIV-1 RNA |
-0.97; -1.53; 0.0; 0.2 | 0.37 |
| SECONDARY Change From Baseline to Week 96 in HIV-1 RNA |
-2.1; 0.0; 0.1 | — |
| SECONDARY Change From Baseline to Week 144 in HIV-1 RNA |
-2.5; 0.2; 0.7 | — |
| SECONDARY Change From Baseline to Week 192 in HIV-1 RNA |
-2.0; 0.0; -0.1 | — |
| SECONDARY Change From Baseline to Week 240 in HIV-1 RNA |
-2.5; -0.4; -1.4 | — |
| SECONDARY Change From Baseline to Week 288 in HIV-1 RNA |
-1.1; -0.8; 0.6 | — |
| SECONDARY Change From Baseline to Week 336 in HIV-1 RNA |
— | — |
| SECONDARY Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count |
69; 49; -43; -12 | 0.71 |
| SECONDARY Change From Baseline to Week 48 in CD4 Count |
152; 148; 15; -47 | 0.47 |
| SECONDARY Change From Baseline to Week 96 in CD4 Count |
152; -6; -69 | — |
| SECONDARY Change From Baseline to Week 144 in CD4 Count |
188; -88; 33 | — |
| SECONDARY Change From Baseline to Week 192 in CD4 Count |
166; -70; -23 | — |
| SECONDARY Change From Baseline to Week 240 in CD4 Count |
221; 571; 258 | — |
| SECONDARY Change From Baseline to Week 288 in CD4 Count |
310; 100; 309 | — |
| SECONDARY Change From Baseline to Week 336 in CD4 Count |
— | — |
| SECONDARY Change From Baseline to Week 24 in CD4 Percentage |
3.0; 2.0; 0.0; -1.0 | 0.26 |
| SECONDARY Change From Baseline to Week 48 in CD4 Percentage |
6.0; 5.0; 2.0; -1.0 | 0.63 |
| SECONDARY Change From Baseline to Week 96 in CD4 Percentage |
5.0; 2.0; 9.0 | — |
| SECONDARY Change From Baseline to Week 144 in CD4 Percentage |
6.5; 0.0; 5.5 | — |
| SECONDARY Change From Baseline to Week 192 in CD4 Percentage |
5.0; 1.9; 4.8 | — |
| SECONDARY Change From Baseline to Week 240 in CD4 Percentage |
10.0; 8.9; 18.9 | — |
| SECONDARY Change From Baseline to Week 288 in CD4 Percentage |
7.4; 4.0; 11.9 | — |
| SECONDARY Change From Baseline to Week 336 in CD4 Percentage |
— | — |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24 |
56.8; 51.2; 0; 12.5 | 0.67 |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48 |
47.7; 53.7; 0; 0 | 0.67 |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96 |
73.7; 5.9; 33.3 | — |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144 |
90.0; 0; 0 | — |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192 |
71.4; 0; 50.0 | — |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240 |
100.0; 0; 100.0 | — |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288 |
100.0; 0; 0 | — |
| SECONDARY Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336 |
— | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24 |
40.9; 41.5; 83.3; 6.3 | 1.00 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 |
34.1; 43.9; 77.8; 0 | 0.38 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 |
63.2; 70.6; 33.3 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 |
70.0; 72.7; 0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192 |
57.1; 80.0; 50.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240 |
75.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288 |
0; 100.0; 0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336 |
— | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 |
20.5; 34.1; 77.8; 0 | 0.22 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 |
27.3; 36.6; 61.1; 0 | 0.48 |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 |
47.4; 58.8; 33.3 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 |
70.0; 45.5; 0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 |
42.9; 60.0; 50.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240 |
75.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288 |
0; 100.0; 0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336 |
— | — |
| SECONDARY Percentage of Participants With Virologic Failure Through Week 48 |
51; 39 | 0.29 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00352053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.