Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Keywords

Phase 3Randomized, Open-LabelTreatment-ExperiencedHighly Active Antiretroviral TherapyHIVTenofovir DFPediatrics

Outcome Measures

Primary Outcomes (1)

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.
48 weeks

Secondary Outcomes (45)

Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
48 weeks
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
48 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
96 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
144 weeks
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
192 weeks
+40 more secondary outcomes

Study Arms (2)

Tenofovir DF

EXPERIMENTAL

Drug: Tenofovir DF

stavudine or zidovudine

ACTIVE COMPARATOR

Drug: ZidovudineDrug: Stavudine

Interventions

Tenofovir DFDrug

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.

Also known as: Viread®

Tenofovir DF

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).

Eligibility Criteria

Age2 Years - 15 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Documented laboratory diagnosis of HIV-1 infection
Plasma HIV-1 RNA \< 400 copies/mL

Sponsors & Collaborators

Gilead Sciences
Industrylead

Study Sites (9)

Jeffrey Goodman Special Care Clinic

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

Memphis, Tennessee, 38105, United States

Related Publications (1)

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.
PMID: 25760565DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirZidovudineStavudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital Diseases

Results Point of Contact

Title: Clinical Trial Disclosures & Transparency
Organization: Gilead Sciences

Study Officials

Gilead Study Director
Gilead Sciences
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

97 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 3, 2007

First Posted

September 14, 2007

Study Start

December 28, 2006

Actual (reported)

Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (45)

Study Arms (2)

Tenofovir DF

stavudine or zidovudine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (45)

Study Arms (2)

Tenofovir DF

stavudine or zidovudine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations