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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00528957

Public ClinicalTrials.gov record NCT00528957. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 1:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00528957
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
97 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 15 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 27, 2006
Primary completion
Apr 5, 2009
Completion
Aug 15, 2017
Last update posted
Mar 13, 2018

2006 – 2017

United States locations

U.S. sites
6
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Jeffrey Goodman Special Care Clinic Los Angeles California 90027
University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases Los Angeles California 90095
Children's Diagnostic and Treatment Center, Inc Fort Lauderdale Florida 33316
University of Florida, Jacksonville Jacksonville Florida 32209
St. Christopher's Hospital for Children Philadelphia Pennsylvania 19134
St. Jude Children's Research Hospital Memphis Tennessee 38105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00528957, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 13, 2018 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00528957 live on ClinicalTrials.gov.

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