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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

Page last updated: August 23, 2015

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