Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
Public ClinicalTrials.gov record NCT00016718. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00016718
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 43 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 90 Days to 21 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
- Aug 2001 (Type not available)
- Primary completion
- Jan 2009 (Actual)
- Completion
- Jan 2009 (Actual)
- Last update posted
- Nov 5, 2021
2001 – 2009
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California | — | — |
| UCSF Pediatric AIDS CRS | San Francisco | California | 941430105 | — |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 802181088 | — |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida | 33161 | — |
| Chicago Children's CRS | Chicago | Illinois | 606143394 | — |
| Rush Univ. Cook County Hosp. Chicago NICHD CRS | Chicago | Illinois | — | — |
| Children's Hosp. of Boston NICHD CRS | Boston | Massachusetts | 021155724 | — |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 016550001 | — |
| Nyu Ny Nichd Crs | New York | New York | 10016 | — |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | — | — |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | — |
| DUMC Ped. CRS | Durham | North Carolina | 277103499 | — |
| St. Jude/UTHSC CRS | Memphis | Tennessee | 381052794 | — |
| Texas Children's Hosp. CRS | Houston | Texas | 77030 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00016718, 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 Nov 5, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00016718 live on ClinicalTrials.gov.