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NCT00016718 · ClinicalTrials.gov registry record · Phase 1
Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT00016718 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 43 participants.
The verdict
NCT00016718, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Efavirenz (EFV)
- DRUG Emtricitabine (FTC)
- DRUG Didanosine (ddI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2001-08 |
| Est. Completion | 2009-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00016718
The ClinicalTrials.gov registry entry for NCT00016718 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Efavirenz (EFV) is the first listed.
NCT00016718 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00016718 about?
NCT00016718 is a clinical study titled "Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs". 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 dif...
What is the current status of trial NCT00016718?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2001-08. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00016718?
The interventions under investigation include: Efavirenz (EFV) (DRUG), Emtricitabine (FTC) (DRUG), Didanosine (ddI) (DRUG).
Who is sponsoring clinical trial NCT00016718?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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