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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00528957
First received: January 3, 2007
Last updated: October 17, 2014
Last verified: October 2014

January 3, 2007
October 17, 2014
December 2006
April 2009   (final data collection date for primary outcome measure)
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.
Primary: Proportion of patients maintaining HIV-1 RNA levels < 400 copies/mL at Week 48 in each arm
Complete list of historical versions of study NCT00528957 on ClinicalTrials.gov Archive Site
  • Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug.
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
    This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks [ Time Frame: 192 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks [ Time Frame: 288 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks [ Time Frame: 336 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
    This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks [ Time Frame: 192 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks [ Time Frame: 288 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks [ Time Frame: 336 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Percentage at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.
  • Change From Baseline in CD4 Percentage at 96 Weeks [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
    This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.
  • Change From Baseline in CD4 Percentage at 144 Weeks [ Time Frame: Baseline and 144 weeks ] [ Designated as safety issue: No ]
    This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.
  • Change From Baseline in CD4 Percentage at 192 Weeks [ Time Frame: Baseline and 192 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Percentage at 240 Weeks [ Time Frame: Baseline and 240 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Percentage at 288 Weeks [ Time Frame: Baseline and 288 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Percentage at 336 Weeks [ Time Frame: Baseline and 336 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
    This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks [ Time Frame: Baseline and 144 weeks ] [ Designated as safety issue: No ]
    This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks [ Time Frame: Baseline and 192 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks [ Time Frame: Baseline and 240 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks [ Time Frame: Baseline and 288 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks [ Time Frame: Baseline and 336 weeks ] [ Designated as safety issue: No ]
Evaluate the safety and tolerability of tenofovir DF in HIV-1 infected children
Not Provided
Not Provided
 
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
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

The purpose of this study is to assess the safety and efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Tenofovir DF
    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.
  • Drug: Zidovudine
    Zidovudine as prescribed by the investigator prior to study entry.
  • Drug: Stavudine
    Stavudine as prescribed by the investigator prior to study entry.
  • Experimental: Tenofovir DF
    Intervention: Drug: Tenofovir DF
  • Active Comparator: stavudine or zidovudine
    Interventions:
    • Drug: Zidovudine
    • Drug: Stavudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
97
December 2023
April 2009   (final data collection date for primary outcome measure)

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

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.

Inclusion Criteria for the Second, Third, and Fourth 96-Week 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.

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)
Both
2 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Panama,   Puerto Rico,   United Kingdom
 
NCT00528957
GS-US-104-0352
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP