HIV InfectionsPhase 3NCT00528957
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
A Phase 3 study testing Tenofovir DF, Zidovudine and Stavudine in people with HIV Infections, run by Gilead Sciences at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir DF, Zidovudine and Stavudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 28 Dec 2006to 16 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States6 sites
Children's Diagnostic and Treatment Center, Inc
Fort Lauderdale, Florida, 33316
University of Florida, Jacksonville
Jacksonville, Florida, 32209
Jeffrey Goodman Special Care Clinic
Los Angeles, California, 90027
University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases
Los Angeles, California, 90095
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
United Kingdom2 sites
Great Ormond Street Hospital
London
Imperial College London, Paediatrics Infectious Diseases
London
About this study
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
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.
- Conditions
- HIV Infections
- Being tested
- Tenofovir DF, Zidovudine, Stavudine
- Keywords
- Phase 3, Randomized, Open-Label, Treatment-Experienced, Highly Active Antiretroviral Therapy, HIV, Tenofovir DF, Pediatrics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir DFDrug
Also called Viread®
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.
ZidovudineDrug
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).
StavudineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir DF | Experimental | Not described Receives: Drug: Tenofovir DF |
| stavudine or zidovudine | Active comparator | Not described Receives: Drug: Zidovudine; Drug: Stavudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (45)
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.
Measured: 48 weeks
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.
Measured: 48 weeks
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.
Measured: 96 weeks
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.
Measured: 144 weeks
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.
Measured: 192 weeks
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.
Measured: 240 weeks
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.
Measured: 288 weeks
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.
Measured: 336 weeks
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.
Measured: 384 weeks
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.
Measured: 432 weeks
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.
Measured: 480 weeks
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.
Measured: 528 weeks
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.
Measured: 48 weeks
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.
Measured: 96 weeks
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.
Measured: 144 weeks
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.
Measured: 192 weeks
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.
Measured: 240 weeks
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.
Measured: 288 weeks
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.
Measured: 336 weeks
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.
Measured: 384 weeks
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.
Measured: 432 weeks
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.
Measured: 480 weeks
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.
Measured: 528 weeks
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.
Measured: Baseline and 48 weeks
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.
Measured: Baseline and 96 weeks
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.
Measured: Baseline and 144 weeks
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.
Measured: Baseline and 192 weeks
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.
Measured: Baseline and 240 weeks
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.
Measured: Baseline and 288 weeks
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.
Measured: Baseline and 336 weeks
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.
Measured: Baseline and 384 weeks
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.
Measured: Baseline and 432 weeks
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.
Measured: Baseline and 480 weeks
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.
Measured: Baseline and 528 weeks
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.
Measured: Baseline and 48 weeks
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.
Measured: Baseline and 96 weeks
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.
Measured: Baseline and 144 weeks
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.
Measured: Baseline and 192 weeks
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.
Measured: Baseline and 240 weeks
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.
Measured: Baseline and 288 weeks
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.
Measured: Baseline and 336 weeks
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.
Measured: Baseline and 384 weeks
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.
Measured: Baseline and 432 weeks
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.
Measured: Baseline and 480 weeks
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.
Measured: Baseline and 528 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study start28 Dec 2006
- Primary completion6 Apr 2009
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528957
- Sponsor's protocol ID
- GS-US-104-0352
- Other IDs
- 2007-003418-32
- Status last verified
- Feb 2018
- First submitted
- 3 Jan 2007
- Last updated
- 14 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 25760565
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00528957
- Acronym / sponsor ID
- GS-US-104-0352
- Conditions
- HIV Infections
- Keywords
- Phase 3, Randomized, Open-Label, Treatment-Experienced, Highly Active Antiretroviral Therapy, HIV, Tenofovir DF, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2006 (actual)
- Primary completion
- 6 Apr 2009 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 22 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir DF | Experimental | Drug: Tenofovir DF |
| stavudine or zidovudine | Active comparator | Drug: Zidovudine, Drug: Stavudine |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Participants receiving ongoing therapy with any of the following
- Nephrotoxic agents
- Systemic chemotherapeutic agents
- Systemic corticosteroids
- Interleukin 2 (IL 2) and other immunomodulating agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir DFAlso: Viread®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. | Drug | Tenofovir DF |
| ZidovudineZidovudine 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 or zidovudine |
| StavudineStavudine 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). | Drug | stavudine or zidovudine |
Primary outcome
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.
45 secondary outcomes
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
Time frame: 48 weeks
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 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 < 400 Copies/mL at 384 Weeks
Time frame: 384 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
Time frame: 432 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
Time frame: 480 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
Time frame: 528 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
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
Time frame: 384 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
Time frame: 432 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
Time frame: 480 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
Time frame: 528 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 Percentage at 384 Weeks
Time frame: Baseline and 384 weeks
Change From Baseline in CD4 Percentage at 432 Weeks
Time frame: Baseline and 432 weeks
Change From Baseline in CD4 Percentage at 480 Weeks
Time frame: Baseline and 480 weeks
Change From Baseline in CD4 Percentage at 528 Weeks
Time frame: Baseline and 528 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25760565Saez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenofovir DF, Zidovudine and Stavudine in people with HIV Infections, run by Gilead Sciences at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, United Kingdom, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00528957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.