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Completed

NCT Number: NCT00528957

Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital del Nino, Panama City, Panama

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenofovir DF

Drug

Tenofovir DF (oral powder or tablet): 300-mg tablets for participants > 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to > 37 kg may be switched from the oral powder to the tenofovir DF tablet.

Other names: Viread®

Zidovudine

Drug

Zidovudine as prescribed by the investigator prior to study entry (pediatric participants < 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).

Stavudine

Drug

Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m^2 every 8 hours; pediatric participants > 12 years of age: 300 mg twice daily).

Primary outcomes

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

    Time frame: 48 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.

Secondary outcomes

  1. Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)

    Time frame: 48 weeks

    This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

  2. Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)

    Time frame: 48 weeks

    This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

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

    Time frame: 96 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.

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

    Time frame: 144 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.

  5. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks

    Time frame: 192 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.

  6. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks

    Time frame: 240 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.

  7. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks

    Time frame: 288 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF.

  8. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks

    Time frame: 336 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.

  9. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks

    Time frame: 384 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.

  10. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks

    Time frame: 432 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.

  11. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks

    Time frame: 480 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.

  12. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks

    Time frame: 528 weeks

    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.

  13. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks

    Time frame: 48 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.

  14. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks

    Time frame: 96 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.

  15. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks

    Time frame: 144 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.

  16. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks

    Time frame: 192 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.

  17. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks

    Time frame: 240 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.

  18. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks

    Time frame: 288 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.

  19. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks

    Time frame: 336 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.

  20. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks

    Time frame: 384 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.

  21. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks

    Time frame: 432 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.

  22. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks

    Time frame: 480 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.

  23. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks

    Time frame: 528 weeks

    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.

  24. Change From Baseline in CD4 Percentage at 48 Weeks

    Time frame: Baseline and 48 weeks

    This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.

  25. Change From Baseline in CD4 Percentage at 96 Weeks

    Time frame: Baseline and 96 weeks

    This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.

  26. Change From Baseline in CD4 Percentage at 144 Weeks

    Time frame: Baseline and 144 weeks

    This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.

  27. Change From Baseline in CD4 Percentage at 192 Weeks

    Time frame: Baseline and 192 weeks

    This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.

  28. Change From Baseline in CD4 Percentage at 240 Weeks

    Time frame: Baseline and 240 weeks

    This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.

  29. Change From Baseline in CD4 Percentage at 288 Weeks

    Time frame: Baseline and 288 weeks

    This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.

  30. Change From Baseline in CD4 Percentage at 336 Weeks

    Time frame: Baseline and 336 weeks

    This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.

  31. Change From Baseline in CD4 Percentage at 384 Weeks

    Time frame: Baseline and 384 weeks

    This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.

  32. Change From Baseline in CD4 Percentage at 432 Weeks

    Time frame: Baseline and 432 weeks

    This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.

  33. Change From Baseline in CD4 Percentage at 480 Weeks

    Time frame: Baseline and 480 weeks

    This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.

  34. Change From Baseline in CD4 Percentage at 528 Weeks

    Time frame: Baseline and 528 weeks

    This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.

  35. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks

    Time frame: Baseline and 48 weeks

    This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.

  36. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks

    Time frame: Baseline and 96 weeks

    This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.

  37. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks

    Time frame: Baseline and 144 weeks

    This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.

  38. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks

    Time frame: Baseline and 192 weeks

    This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.

  39. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks

    Time frame: Baseline and 240 weeks

    This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.

  40. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks

    Time frame: Baseline and 288 weeks

    This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.

  41. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks

    Time frame: Baseline and 336 weeks

    This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.

  42. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks

    Time frame: Baseline and 384 weeks

    This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.

  43. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks

    Time frame: Baseline and 432 weeks

    This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.

  44. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks

    Time frame: Baseline and 480 weeks

    This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.

  45. Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks

    Time frame: Baseline and 528 weeks

    This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy

Important dates

Study start
2006
Primary completion
2009
Study completion
2017
First posted
Sep 14, 2007
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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