Back to resultsSafety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tenofovir DF
Zidovudine
Stavudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Phase 3, Randomized, Open-Label, Treatment-Experienced, Highly Active Antiretroviral Therapy, HIV, Tenofovir DF, Pediatrics
Eligibility 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.
Sites / Locations
- Jeffrey Goodman Special Care Clinic
- University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases
- Children's Diagnostic and Treatment Center, Inc
- University of Florida, Jacksonville
- St. Christopher's Hospital for Children
- St. Jude Children's Research Hospital
- Hospital del Nino
- Great Ormond Street Hospital
- Imperial College London, Paediatrics Infectious Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tenofovir DF
stavudine or zidovudine
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
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)
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.
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
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.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
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
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
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 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
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
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
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 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
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
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
This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 240 Weeks
This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 288 Weeks
This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 336 Weeks
This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 384 Weeks
This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 432 Weeks
This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 480 Weeks
This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.
Change From Baseline in CD4 Percentage at 528 Weeks
This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 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
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
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
This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks
This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks
This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks
This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks
This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks
This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00528957
Brief Title
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 28, 2006 (Actual)
Primary Completion Date
April 6, 2009 (Actual)
Study Completion Date
August 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Phase 3, Randomized, Open-Label, Treatment-Experienced, Highly Active Antiretroviral Therapy, HIV, Tenofovir DF, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenofovir DF
Arm Type
Experimental
Arm Title
stavudine or zidovudine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tenofovir DF
Other Intervention Name(s)
Viread®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
Description
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.
Time Frame
48 weeks
Title
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
Description
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.
Time Frame
48 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.
Time Frame
96 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.
Time Frame
144 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.
Time Frame
192 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.
Time Frame
240 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF.
Time Frame
288 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.
Time Frame
336 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.
Time Frame
384 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.
Time Frame
432 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.
Time Frame
480 weeks
Title
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.
Time Frame
528 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.
Time Frame
48 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.
Time Frame
96 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.
Time Frame
144 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.
Time Frame
192 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.
Time Frame
240 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.
Time Frame
288 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.
Time Frame
336 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.
Time Frame
384 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.
Time Frame
432 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.
Time Frame
480 weeks
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
Description
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.
Time Frame
528 weeks
Title
Change From Baseline in CD4 Percentage at 48 Weeks
Description
This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.
Time Frame
Baseline and 48 weeks
Title
Change From Baseline in CD4 Percentage at 96 Weeks
Description
This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.
Time Frame
Baseline and 96 weeks
Title
Change From Baseline in CD4 Percentage at 144 Weeks
Description
This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.
Time Frame
Baseline and 144 weeks
Title
Change From Baseline in CD4 Percentage at 192 Weeks
Description
This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.
Time Frame
Baseline and 192 weeks
Title
Change From Baseline in CD4 Percentage at 240 Weeks
Description
This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.
Time Frame
Baseline and 240 weeks
Title
Change From Baseline in CD4 Percentage at 288 Weeks
Description
This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.
Time Frame
Baseline and 288 weeks
Title
Change From Baseline in CD4 Percentage at 336 Weeks
Description
This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.
Time Frame
Baseline and 336 weeks
Title
Change From Baseline in CD4 Percentage at 384 Weeks
Description
This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.
Time Frame
Baseline and 384 weeks
Title
Change From Baseline in CD4 Percentage at 432 Weeks
Description
This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.
Time Frame
Baseline and 432 weeks
Title
Change From Baseline in CD4 Percentage at 480 Weeks
Description
This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.
Time Frame
Baseline and 480 weeks
Title
Change From Baseline in CD4 Percentage at 528 Weeks
Description
This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.
Time Frame
Baseline and 528 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks
Description
This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.
Time Frame
Baseline and 48 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
Description
This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.
Time Frame
Baseline and 96 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
Description
This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.
Time Frame
Baseline and 144 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks
Description
This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.
Time Frame
Baseline and 192 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
Description
This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.
Time Frame
Baseline and 240 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
Description
This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.
Time Frame
Baseline and 288 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks
Description
This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.
Time Frame
Baseline and 336 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks
Description
This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.
Time Frame
Baseline and 384 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks
Description
This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.
Time Frame
Baseline and 432 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks
Description
This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.
Time Frame
Baseline and 480 weeks
Title
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks
Description
This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.
Time Frame
Baseline and 528 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Jeffrey Goodman Special Care Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Diagnostic and Treatment Center, Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Florida, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Hospital del Nino
City
Panama City
Country
Panama
Facility Name
Great Ormond Street Hospital
City
London
Country
United Kingdom
Facility Name
Imperial College London, Paediatrics Infectious Diseases
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25760565
Citation
Saez-Llorens X, Castano E, Rathore M, Church J, Deville J, Gaur A, Estripeaut D, White K, Arterburn S, Enejosa JV, Cheng AK, Chuck SL, Rhee MS. A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. Pediatr Infect Dis J. 2015 Apr;34(4):376-82. doi: 10.1097/INF.0000000000000289.
Results Reference
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Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
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