Clinical trial

Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV…

NCT00016718 · National Institute of Allergy and Infectious Diseases (NIAID), NIH · Completed

Key facts

NCT number NCT00016718
Title Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
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
Lead sponsor National Institute of Allergy and Infectious Diseases (NIAID), NIH
Collaborators Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NIH
Status Completed
Phase Phase 1/Phase 2
Study type Interventional
Conditions HIV Infections
Intervention type Drug
Interventions Didanosine (ddI), Efavirenz (EFV), Emtricitabine (FTC)
Enrollment 43
Start date Aug 1, 2001
Primary completion Jan 1, 2009
Completion Jan 1, 2009
First posted Aug 31, 2001
Last update posted Nov 5, 2021
Countries Puerto Rico, United States

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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