Trial record 10 of 20 for:
" January 02, 2007":" February 02, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00528957
First received: January 3, 2007
Last updated: June 18, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tenofovir DF Drug: Zidovudine Drug: Stavudine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug.
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 192 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks [ Time Frame: 288 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks [ Time Frame: 336 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 192 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks [ Time Frame: 288 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks [ Time Frame: 336 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Percentage at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 144 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 192 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Percentage at 240 Weeks [ Time Frame: Baseline and 240 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Percentage at 288 Weeks [ Time Frame: Baseline and 288 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Percentage at 336 Weeks [ Time Frame: Baseline and 336 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 144 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 192 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks [ Time Frame: Baseline and 240 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks [ Time Frame: Baseline and 288 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks [ Time Frame: Baseline and 336 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 97 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | August 2014 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tenofovir DF |
Drug: 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: stavudine or zidovudine |
Drug: Zidovudine
Zidovudine as prescribed by the investigator prior to study entry.
Drug: Stavudine
Stavudine as prescribed by the investigator prior to study entry.
|
Eligibility| Ages Eligible for Study: | 2 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528957
Locations
| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| Children's Diagnostic and Treatment Center, Inc | |
| Fort Lauderdale, Florida, United States, 33316 | |
| University of Florida, Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Pennsylvania | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Mephis, Tennessee, United States, 38105 | |
| Panama | |
| Hospital del Nino | |
| Panama City, Panama | |
| Puerto Rico | |
| San Juan Hospital | |
| San Juan, Puerto Rico, 00936 | |
| United Kingdom | |
| Great Ormond Street Hospital | |
| London, United Kingdom | |
| Imperial College London, Paediatrics Infectious Diseases | |
| London, United Kingdom | |
Sponsors and Collaborators
Gilead Sciences
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00528957 History of Changes |
| Other Study ID Numbers: | GS-US-104-0352 |
| Study First Received: | January 3, 2007 |
| Results First Received: | February 15, 2012 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
Phase 3 Randomized, Open-Label Treatment-Experienced Highly Active Antiretroviral Therapy |
HIV Tenofovir DF Pediatrics |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Stavudine |
Tenofovir Tenofovir disoproxil Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 23, 2013