Phase 3
Completed N=97
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
Source: ClinicalTrials.gov NCT00528957 ↗Enrolled (actual)
97
Serious AEs
10.2%
Results posted
Mar 2012
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 — 83.3; 91.8; 85.4 percentage of participants
Summary
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 |
83.3; 91.8; 85.4 | — |
| SECONDARY Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) |
88.6; 89.6 | — |
| SECONDARY Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot) |
75.0; 81.3 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 |
81.6; 85.4; 83.5 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 |
73.7; 87.5; 80.8 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks |
70.6; 82.5; 77.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks |
70.6; 75.7; 73.2 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks |
81.5; 67.6; 73.4 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks |
90.9; 100.0; 95.3 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks |
100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks |
100.0; 85.7; 95.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks |
88.9; 100.0; 90.9 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks |
70.8; 85.7; 68.5 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks |
76.3; 68.3; 72.2 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks |
63.2; 75.0; 69.2 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks |
67.6; 75.0; 71.6 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks |
70.6; 73.0; 71.8 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks |
81.5; 62.2; 70.3 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks |
86.4; 90.5; 88.4 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks |
88.2; 100.0; 92.3 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks |
100.0; 71.4; 90.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks |
77.8; 50.0; 72.7 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks |
100.0; 100.0 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 48 Weeks |
0.3; 1.1; 0.6 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 96 Weeks |
1.3; -0.1; 0.6 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 144 Weeks |
0.8; -0.1; 0.3 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 192 Weeks |
1.1; 0.6; 0.8 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 240 Weeks |
1.3; -0.9; 0.1 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 288 Weeks |
2.0; 0.5; 1.3 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 336 Weeks |
2.0; 0.8; 1.4 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 384 Weeks |
0.5; 1.6; 0.9 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 432 Weeks |
0.3; 2.9; 1.1 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 480 Weeks |
2.3; 5.0; 2.9 | — |
| SECONDARY Change From Baseline in CD4 Percentage at 528 Weeks |
4.5; 4.5 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks |
-97; -11; 2 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks |
-77; -56; -67 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks |
-139; -146; -142 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks |
-304; -177; -233 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks |
-369; -296; -329 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks |
-346; -256; -302 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks |
-415; -283; -350 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks |
-620; -305; -512 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks |
-795; -302; -631 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks |
-923; -448; -813 | — |
| SECONDARY Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks |
-710; -710 | — |
Eligibility Criteria
Major Inclusion Criteria:
- Documented laboratory diagnosis of HIV-1 infection
- Plasma HIV-1 RNA < 400 copies/mL
- Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks
- Naive to tenofovir DF
Key Inclusion Criteria for the First 96-Week Extension
- Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study
- <18 years of age (at the start of the extension)
- Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.
Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension
- Completed of treatment with study drug in the first extension phase
- <18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.
Key Exclusion Criteria
- Participants receiving ongoing therapy with any of the following
- Nephrotoxic agents
- Systemic chemotherapeutic agents
- Systemic corticosteroids
- Interleukin 2 (IL 2) and other immunomodulating agents
- Investigational agents
- Pregnant or lactating participants
- Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication
- Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening
- Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis)
- Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00528957). 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.