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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00528957
First Posted: September 14, 2007
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
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.

Condition Intervention Phase
HIV Infections Drug: Tenofovir DF Drug: Zidovudine Drug: Stavudine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks [ Time Frame: 192 weeks ]
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks [ Time Frame: 240 weeks ]
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks [ Time Frame: 288 weeks ]
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks [ Time Frame: 336 weeks ]
  • 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.

  • 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.

  • 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.

  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks [ Time Frame: 192 weeks ]
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks [ Time Frame: 240 weeks ]
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks [ Time Frame: 288 weeks ]
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks [ Time Frame: 336 weeks ]
  • 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.

  • 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.

  • 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.

  • Change From Baseline in CD4 Percentage at 192 Weeks [ Time Frame: Baseline and 192 weeks ]
  • Change From Baseline in CD4 Percentage at 240 Weeks [ Time Frame: Baseline and 240 weeks ]
  • Change From Baseline in CD4 Percentage at 288 Weeks [ Time Frame: Baseline and 288 weeks ]
  • Change From Baseline in CD4 Percentage at 336 Weeks [ Time Frame: Baseline and 336 weeks ]
  • 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.

  • 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.

  • 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.

  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks [ Time Frame: Baseline and 192 weeks ]
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks [ Time Frame: Baseline and 240 weeks ]
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks [ Time Frame: Baseline and 288 weeks ]
  • Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks [ Time Frame: Baseline and 336 weeks ]

Enrollment: 97
Actual Study Start Date: December 28, 2006
Study Completion Date: August 16, 2017
Primary Completion Date: April 9, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenofovir DF 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.
Active Comparator: stavudine or zidovudine Drug: Zidovudine
Zidovudine as prescribed by the investigator prior to study entry.
Drug: Stavudine
Stavudine as prescribed by the investigator prior to study entry.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528957


Locations
United States, California
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90027
University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases
Los Angeles, California, United States, 90095
United States, Florida
Children's Diagnostic and Treatment Center, Inc
Fort Lauderdale, Florida, United States, 33316
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32209
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Panama
Hospital del Nino
Panama City, Panama
United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Imperial College London, Paediatrics Infectious Diseases
London, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00528957     History of Changes
Other Study ID Numbers: GS-US-104-0352
First Submitted: January 3, 2007
First Posted: September 14, 2007
Results First Submitted: February 15, 2012
Results First Posted: March 22, 2012
Last Update Posted: October 6, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Phase 3
Randomized, Open-Label
Treatment-Experienced
Highly Active Antiretroviral Therapy
HIV
Tenofovir DF
Pediatrics

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Zidovudine
Stavudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Antimetabolites