- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00528957
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
February 14, 2018 updated by: Gilead Sciences
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Panama City, Panama
- Hospital del Nino
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London, United Kingdom
- Great Ormond Street Hospital
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London, United Kingdom
- Imperial College London, Paediatrics Infectious Diseases
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California
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Los Angeles, California, United States, 90027
- Jeffrey Goodman Special Care Clinic
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Los Angeles, California, United States, 90095
- University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Children's Diagnostic and Treatment Center, Inc
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Jacksonville, Florida, United States, 32209
- University of Florida, Jacksonville
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19134
- St. Christopher's Hospital for Children
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Tenofovir DF
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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:
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Active Comparator: stavudine or zidovudine
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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 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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Time Frame: 48 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.
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48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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48 weeks
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Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
Time Frame: 48 weeks
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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.
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48 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Time Frame: 96 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.
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96 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Time Frame: 144 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.
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144 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
Time Frame: 192 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.
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192 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
Time Frame: 240 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.
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240 weeks
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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.
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288 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
Time Frame: 336 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.
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336 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
Time Frame: 384 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.
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384 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
Time Frame: 432 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.
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432 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
Time Frame: 480 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.
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480 weeks
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
Time Frame: 528 weeks
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This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.
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528 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks
Time Frame: 48 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.
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48 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
Time Frame: 96 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.
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96 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
Time Frame: 144 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.
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144 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks
Time Frame: 192 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.
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192 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
Time Frame: 240 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.
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240 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
Time Frame: 288 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.
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288 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
Time Frame: 336 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.
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336 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
Time Frame: 384 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.
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384 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
Time Frame: 432 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.
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432 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
Time Frame: 480 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.
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480 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
Time Frame: 528 weeks
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This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.
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528 weeks
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Change From Baseline in CD4 Percentage at 48 Weeks
Time Frame: Baseline and 48 weeks
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This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.
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Baseline and 48 weeks
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Change From Baseline in CD4 Percentage at 96 Weeks
Time Frame: Baseline and 96 weeks
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This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.
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Baseline and 96 weeks
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Change From Baseline in CD4 Percentage at 144 Weeks
Time Frame: Baseline and 144 weeks
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This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.
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Baseline and 144 weeks
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Change From Baseline in CD4 Percentage at 192 Weeks
Time Frame: Baseline and 192 weeks
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This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.
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Baseline and 192 weeks
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Change From Baseline in CD4 Percentage at 240 Weeks
Time Frame: Baseline and 240 weeks
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This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.
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Baseline and 240 weeks
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Change From Baseline in CD4 Percentage at 288 Weeks
Time Frame: Baseline and 288 weeks
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This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.
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Baseline and 288 weeks
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Change From Baseline in CD4 Percentage at 336 Weeks
Time Frame: Baseline and 336 weeks
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This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.
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Baseline and 336 weeks
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Change From Baseline in CD4 Percentage at 384 Weeks
Time Frame: Baseline and 384 weeks
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This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.
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Baseline and 384 weeks
|
Change From Baseline in CD4 Percentage at 432 Weeks
Time Frame: Baseline and 432 weeks
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This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.
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Baseline and 432 weeks
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Change From Baseline in CD4 Percentage at 480 Weeks
Time Frame: Baseline and 480 weeks
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This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.
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Baseline and 480 weeks
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Change From Baseline in CD4 Percentage at 528 Weeks
Time Frame: Baseline and 528 weeks
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This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.
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Baseline and 528 weeks
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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks
Time Frame: Baseline and 48 weeks
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This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.
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Baseline and 48 weeks
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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
Time Frame: Baseline and 96 weeks
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This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.
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Baseline and 96 weeks
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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
Time Frame: Baseline and 144 weeks
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This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.
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Baseline and 144 weeks
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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks
Time Frame: Baseline and 192 weeks
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This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.
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Baseline and 192 weeks
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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
Time Frame: Baseline and 240 weeks
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This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.
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Baseline and 240 weeks
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Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
Time Frame: Baseline and 288 weeks
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This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.
|
Baseline and 288 weeks
|
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.
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Baseline and 336 weeks
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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.
|
Baseline and 384 weeks
|
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.
|
Baseline and 432 weeks
|
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.
|
Baseline and 480 weeks
|
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.
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Baseline and 528 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2006
Primary Completion (Actual)
April 6, 2009
Study Completion (Actual)
August 16, 2017
Study Registration Dates
First Submitted
January 3, 2007
First Submitted That Met QC Criteria
September 10, 2007
First Posted (Estimate)
September 14, 2007
Study Record Updates
Last Update Posted (Actual)
March 14, 2018
Last Update Submitted That Met QC Criteria
February 14, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Tenofovir
- Zidovudine
- Stavudine
Other Study ID Numbers
- GS-US-104-0352
- 2007-003418-32 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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