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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Panama
      • Panama City, Panama
        • Hospital del Niño
  • United Kingdom
      • London, United Kingdom
        • Great Ormond Street Hospital
      • London, United Kingdom
        • Imperial College London, Paediatrics Infectious Diseases
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Jeffrey Goodman Special Care Clinic
      • Los Angeles, California, United States, 90095
        • University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Children's Diagnostic and Treatment Center, Inc
      • Jacksonville, Florida, United States, 32209
        • University of Florida, Jacksonville
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other Names:
  • Viread®
Active Comparator: stavudine or zidovudine
Drug: Zidovudine
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).
Drug: Stavudine
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Time Frame: 48 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
48 weeks
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 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 < 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.
48 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Time Frame: 96 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.
96 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Time Frame: 144 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.
144 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
Time Frame: 192 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.
192 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
Time Frame: 240 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.
240 weeks
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.
288 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
Time Frame: 336 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.
336 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
Time Frame: 384 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.
384 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
Time Frame: 432 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.
432 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
Time Frame: 480 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.
480 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
Time Frame: 528 weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.
528 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks
Time Frame: 48 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.
48 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
Time Frame: 96 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.
96 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
Time Frame: 144 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.
144 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks
Time Frame: 192 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.
192 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
Time Frame: 240 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.
240 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
Time Frame: 288 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.
288 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
Time Frame: 336 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.
336 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
Time Frame: 384 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.
384 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
Time Frame: 432 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.
432 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
Time Frame: 480 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.
480 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
Time Frame: 528 weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.
528 weeks
Change From Baseline in CD4 Percentage at 48 Weeks
Time Frame: Baseline and 48 weeks
This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.
Baseline and 48 weeks
Change From Baseline in CD4 Percentage at 96 Weeks
Time Frame: Baseline and 96 weeks
This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.
Baseline and 96 weeks
Change From Baseline in CD4 Percentage at 144 Weeks
Time Frame: Baseline and 144 weeks
This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.
Baseline and 144 weeks
Change From Baseline in CD4 Percentage at 192 Weeks
Time Frame: Baseline and 192 weeks
This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.
Baseline and 192 weeks
Change From Baseline in CD4 Percentage at 240 Weeks
Time Frame: Baseline and 240 weeks
This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.
Baseline and 240 weeks
Change From Baseline in CD4 Percentage at 288 Weeks
Time Frame: Baseline and 288 weeks
This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.
Baseline and 288 weeks
Change From Baseline in CD4 Percentage at 336 Weeks
Time Frame: Baseline and 336 weeks
This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.
Baseline and 336 weeks
Change From Baseline in CD4 Percentage at 384 Weeks
Time Frame: Baseline and 384 weeks
This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.
Baseline and 384 weeks
Change From Baseline in CD4 Percentage at 432 Weeks
Time Frame: Baseline and 432 weeks
This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.
Baseline and 432 weeks
Change From Baseline in CD4 Percentage at 480 Weeks
Time Frame: Baseline and 480 weeks
This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.
Baseline and 480 weeks
Change From Baseline in CD4 Percentage at 528 Weeks
Time Frame: Baseline and 528 weeks
This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.
Baseline and 528 weeks
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks
Time Frame: Baseline and 48 weeks
This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.
Baseline and 48 weeks
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
Time Frame: Baseline and 96 weeks
This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.
Baseline and 96 weeks
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
Time Frame: Baseline and 144 weeks
This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.
Baseline and 144 weeks
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks
Time Frame: Baseline and 192 weeks
This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.
Baseline and 192 weeks
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
Time Frame: Baseline and 240 weeks
This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.
Baseline and 240 weeks
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
Time Frame: Baseline and 288 weeks
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.
Baseline and 336 weeks
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.
Baseline and 528 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 28, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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