Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Tenofovir DF (Drug); Zidovudine (Drug); Stavudine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s): Sean Bennett, MD, Study Director, Affiliation: Gilead Sciences
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Secondary outcome: Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks Change From Baseline in CD4 Percentage at 48 Weeks Change From Baseline in CD4 Percentage at 96 Weeks Change From Baseline in CD4 Percentage at 144 Weeks Change From Baseline in CD4 Percentage at 192 Weeks Change From Baseline in CD4 Percentage at 240 Weeks Change From Baseline in CD4 Percentage at 288 Weeks Change From Baseline in CD4 Percentage at 336 Weeks Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks
Eligibility
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
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
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)
Locations and Contacts
Hospital del Nino, Panama City, Panama
San Juan Hospital, San Juan 00936, Puerto Rico
Great Ormond Street Hospital, London, United Kingdom
Imperial College London, Paediatrics Infectious Diseases, London, United Kingdom
Children's Hospital Los Angeles, Los Angeles, California 90027, United States
University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases, Los Angeles, California 90095, United States
Children's Diagnostic and Treatment Center, Inc, Fort Lauderdale, Florida 33316, United States
University of Florida, Jacksonville, Jacksonville, Florida 32209, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States
St. Jude Children's Research Hospital, Mephis, Tennessee 38105, United States
Additional Information
Starting date: December 2006
Last updated: April 22, 2015
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