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

NCT00528957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2018-03-14

Study results available
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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.

Conditions

  • HIV Infections

Interventions

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.

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).

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-28
Primary Completion
2009-04-06
Completion
2017-08-16
FDA Drug
Yes

Countries

  • United States
  • Panama
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528957 on ClinicalTrials.gov