Clinical trialNCT00016718CompletedPhase 1/PHASE2Interventional

Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment43HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Mobeen H. Rathore, MD
Pediatric Infectious Diseases/Immunology, University of Florida Health Science Center
Study Chair
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Ross E. McKinney, Jr., MD
Duke University
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

San Juan City Hosp. Pr Nichd Crs
San Juan, Puerto Rico
Univ. of Puerto Rico Ped. Hiv/aids Research Program Crs
San Juan, Puerto Rico

United States

Ucsd Maternal, Child, and Adolescent Hiv Crs
San Diego, California, United States
Ucsf Pediatric Aids Crs
San Francisco, California, United States
Univ. of Colorado Denver Nichd Crs
Aurora, Colorado, United States
Howard Univ. Washington Dc Nichd Crs
Washington D.C., District of Columbia, United States
Univ. of Florida Jacksonville Nichd Crs
Jacksonville, Florida, United States
Univ. of Miami Ped. Perinatal Hiv/aids Crs
Miami, Florida, United States
Chicago Children'S Crs
Chicago, Illinois, United States
Rush Univ. Cook County Hosp. Chicago Nichd Crs
Chicago, Illinois, United States
Children'S Hosp. of Boston Nichd Crs
Boston, Massachusetts, United States
Wne Maternal Pediatric Adolescent Aids Crs
Worcester, Massachusetts, United States
Harlem Hosp. Ctr. Ny Nichd Crs
New York, New York, United States
Nyu Ny Nichd Crs
New York, New York, United States
Suny Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Dumc Ped. Crs
Durham, North Carolina, United States
St. Jude/uthsc Crs
Memphis, Tennessee, United States
Texas Children'S Hosp. Crs
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Didanosine →Efavirenz →Emtricitabine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2001
Primary completion: 31 Jan 2009
Completion: 31 Jan 2009
Last update posted: 5 Nov 2021
Registered enrollment: 43
Registry id: NCT00016718

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.