Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments tenofovir df, zidovudine, stavudine
Phase phase 3
Sponsor Gilead Sciences
Start date December 2006
End date April 2009
Trial size 97 participants
Trial identifier NCT00528957, GS-US-104-0352

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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)
zidovudine
Zidovudine as prescribed by the investigator prior to study entry.
stavudine
Stavudine as prescribed by the investigator prior to study entry.

Primary Outcomes

Measure
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
time frame: 48 weeks

Secondary Outcomes

Measure
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
time frame: 48 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
time frame: 96 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
time frame: 144 weeks
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
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
time frame: 96 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
time frame: 144 weeks
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
Change From Baseline in CD4 Percentage at 96 Weeks
time frame: Baseline and 96 weeks
Change From Baseline in CD4 Percentage at 144 Weeks
time frame: Baseline and 144 weeks
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
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
time frame: Baseline and 96 weeks
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
time frame: Baseline and 144 weeks
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

Eligibility Criteria

Male or female participants from 2 years up to 11 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.